Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications, 35691-35698 [2012-14476]

Download as PDF 35691 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 2012, THROUGH MARCH 31, 2012—Continued PMA No., Docket No. Applicant Trade name P060008.S046, FDA–2012–M–0210 ... Boston Scientific Corp ......................... P030025.S086, FDA–2012–M–0209 ... Boston Scientific Corp ......................... P110023, FDA–2012–M–0221 ............ ev3, Inc ................................................ P070004, FDA–2012–M–0250 ............ Sientra, Inc .......................................... ´ TAXUS Liberte Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems). TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems). Everflex Self-Expanding Peripheral Stent System (Everflex). SIENTRA Silicone Gel Breast Implants. II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm and https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ HDEApprovals/ucm161827.htm. Dated: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–14486 Filed 6–13–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Update to Electronic Common Technical Document Module 1 AGENCY: Food and Drug Administration, HHS. pmangrum on DSK3VPTVN1PROD with NOTICES ACTION: Notice of meeting. The Food and Drug Administration (FDA) is announcing the following meeting: Update to Electronic Common Technical Document Module 1. The topic to be discussed is final documentation of the Electronic Common Technical Document (eCTD) Module 1, which is used for electronic submission of administrative and prescribing information by industry. The purpose of the meeting is to provide clarification and answer questions from industry and software vendors regarding the changes being made to this module. Registration is required in advance and participation will be limited. DATES: Date and Time: The meeting will be held on Tuesday, September 18, 2012, from 8 a.m. to 11:30 a.m. VerDate Mar<15>2010 14:34 Jun 13, 2012 The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Great Room 1503, Silver Spring, MD 20993. The following link contains public meeting attendee information as well as frequently asked questions and answers regarding public meetings at White Oak: https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. CONTACT: Julie Quinonez, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1135, Silver Spring, MD 20993, 301–796– 0282, FAX: 301–796–9876, email: Julie.Quinonez@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) to Julie Quinonez (see Contact). Registrations will be accepted in the order that they are received with a limit of 350. SUPPLEMENTARY INFORMATION: The eCTD is an International Conference on Harmonization (ICH) standard based on specifications developed by ICH and its member parties. The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have been receiving submissions in the eCTD format since 2003, and the eCTD has been the standard for electronic submissions to CDER and CBER since January 1, 2008. In fact, the majority of new electronic submissions are now received in eCTD format. Since adoption of the eCTD standard, it has become necessary to update the administrative portion of the eCTD Module 1 to reflect regulatory changes; to provide clarification of business rules for submission, processing, and review; to refine the characterization of promotional labeling and advertising material; and to facilitate automated processing of LOCATION: Jkt 226001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Approval date February 22, 2012. February 22, 2012. March 7, 2012. March 9, 2012. submissions. In the process of considering these changes, FDA has previously made available for comment versions of documents that support making regulatory submissions in electronic format using the (eCTD) specifications. These draft documents represented FDA’s major updates to Module 1 of the eCTD based on previous comments. FDA will make available revised versions of these documents in preparation for this meeting. These documents will be posted at: https://www.fda.gov/Drugs/ DevelopmentApprovalProcess/ FormsSubmissionRequirements/ ElectronicSubmissions/ucm253101.htm. If you need special accommodations due to a disability, please contact Julie Quinonez (see Contact) at least 7 days in advance. Dated: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–14469 Filed 6–13–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0517] Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing its intention to deem to be withdrawn any abbreviated new drug applications (ANDAs) that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since July 8, 1991. Each of these applications will be SUMMARY: E:\FR\FM\14JNN1.SGM 14JNN1 35692 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices pmangrum on DSK3VPTVN1PROD with NOTICES deemed to have been withdrawn voluntarily by the applicant unless the applicant informs the Agency in writing that it intends to actively pursue approval of the application(s) (see DATES). DATES: The applicant of an ANDA covered by this notice that intends to actively pursue approval of its application must submit a written notification to FDA by August 13, 2012. ADDRESSES: Applicants should submit written notifications to the ANDA archival file to the Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Document Control Room, MPN7, 7620 Standish Pl., Rockville, MD 20855. A copy of written notifications should also be submitted to Thomas Hinchliffe, Center for Drug Evaluation and Research (HFD–617), Food and Drug Administration, 7500 Standish Pl., rm. N–142, MPN2, Rockville, MD 20855, FAX: 240–276– 8440, email: inactiveandas@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Thomas Hinchliffe, Center for Drug Evaluation and Research (HFD–617), Food and Drug Administration, 7500 Standish Pl., rm. N–142, MPN2, Rockville, MD 20855, 240–276–8433, FAX: 240–276–9310, email: inactiveandas@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA has identified 364 ANDAs for which FDA has not received any communication from the ANDA applicant since July 8, 1991, or earlier (Inactive ANDAs). (See section IV of this document for the list of Inactive ANDAs). For purposes of this document, the term ‘‘applicant’’ includes any successor in interest. FDA’s regulations provide that the Agency will consider withdrawn any application for which the applicant has not contacted the Agency about its intention regarding such application within 1 year after issuance of a complete response letter to the applicant (see 21 CFR 314.110(c)). The Inactive ANDAs, however, predate, and consequently are not subject to this regulation. Therefore, the Inactive ANDAs have not been deemed withdrawn although there has been no communication from the applicants since July 8, 1991, or earlier. II. Withdrawal of Inactive ANDAs At this time, the Agency is announcing its intention to deem all Inactive ANDAs to have been voluntarily withdrawn by the respective applicants as of August 13, 2012, unless VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 the applicant informs the Agency in writing by the date set forth under DATES in this document of its intent to actively pursue approval of the application. Therefore, in the absence of a written notice with respect to an Inactive ANDA by the date specified in this notice, the ANDA will be considered to have been withdrawn by the applicant. No further notice of the withdrawal of Inactive ANDAs will be provided. Withdrawal of an unapproved application is without prejudice to resubmission of that application (21 CFR 314.65). Because of the length of time that has passed since these applications were submitted, FDA strongly recommends that any applicant intending to actively pursue approval review the application carefully to determine whether it satisfies current ANDA requirements (21 CFR part 314). III. Action by the Applicant If the applicant wishes to actively pursue approval of an Inactive ANDA and does not wish the application to be deemed by FDA to have been voluntarily withdrawn, the applicant must inform the Agency in writing within the time specified in this document. Written notice should be provided to Thomas Hinchliffe and the Office of Generic Drugs (see ADDRESSES). FDA also asks any applicant that agrees to consider its application to be voluntarily withdrawn to send a written notice to Thomas Hinchliffe and the Office of Generic Drugs (see ADDRESSES) to confirm that agreement. However, applicants of Inactive ANDAs covered by this notice who wish their applications to be withdrawn are not required to provide written notice to FDA. IV. Details About Inactive ANDAs Information about the Inactive ANDAs is listed in this section of the document. To protect applicant confidentiality, this notice lists the application number and drug name for each Inactive ANDA and separately lists the name of the applicant as shown in the information on file with FDA, without linking identified applicants with specific applications or drug names. In some cases, the identified applicants may no longer exist as ongoing business entities. If an identified applicant is unsure which application(s) belong to it (if any), it may contact Thomas Hinchliffe (see FOR FURTHER INFORMATION CONTACT). Alphabetical List of Abbreviated New Drug Application Applicants 1st Texas Pharmaceuticals, Inc., Subsidiary of Scherer Laboratories Inc. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Abraxis Pharmaceutical Products AH Robins, Co. Alpharma US Pharmaceuticals Division Ambix Laboratories Division of Organics Corp America Ankerfarm SpA Ankerman SpA Antibioticos SA Arcum Pharmaceutical Corp. Banner Pharmacaps, Inc. Barr Laboratories, Inc. Baxter Healthcare Corp. Beecham Laboratories Division of Beecham Inc. Beecham SA Bel Mar Laboratories, Inc. Biocraft Laboratories, Inc. Biometric Testing, Inc. Boots Laboratories, Inc., Division of Boots Pharmaceuticals Inc. Bristol Laboratories, Inc., Division of Bristol Myers Co. Bristol Myers Co. International Division Bristol Myers Industrial Division Bristol Myers Squibb Camall Co., Inc. Carlo Erba SpA Century Pharmaceuticals, Inc. Chemibiotic Ireland, Ltd. Chromalloy Laboratories Division of Chromalloy Pharmaceuticals, Inc. Clifford Chemical Corp. CM Bundy Co. Comatic Laboratories, Inc. Credo Co. Delco Chemical Co., Inc. Dell Laboratories, Inc. Dermasave Laboratories, Inc. Dista Products Co. Division of Eli Lilly & Co. DM Pharmaceuticals, Inc. Dorasol Laboratories Dunhall Pharmaceuticals, Inc. ER Squibb and Sons Pharmaceutical Laboratories Ersana, Inc., Subsidiary of ER Squibb and Sons Everylife Fallek Products Co., Inc. Farmila Farmaceutica Faton Pharmaceuticals, Inc. Fermion Oy Ferndale Laboratories, Inc. Fisons Corp. Forest Laboratories, Inc. Forest Pharmaceuticals, Inc. Forrest Laboratories, Inc. G & W Co. Glenwood Laboratories, Inc. Global Pharmaceutical Corp. Gruppo Lepetit SpA Subsidiary of Merrell Dow Pharmaceuticals, Inc. Heather Drug Co., Inc. Herald Pharmacal, Inc. Hoffmann La Roche, Inc. ICI Ltd. Ingram Pharmaceutical Co. Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc. E:\FR\FM\14JNN1.SGM 14JNN1 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices ISF Kasar Laboratories Division of Kasar Co. Kasco EFCO Laboratories, Inc., Division of Byk Gulden, Inc. KV Pharmaceutical, Co. Lannett Co, Inc. Lederle Laboratories Division of American Cyanamid Co. Leiner Health Products, Inc. Lemmon Co. Subsidiary of Tag Pharmaceutical, Inc. Life Laboratories, Inc. Linden Laboratories, Inc., Subsidiary of Chromalloy American Corp. Luitpold Pharmaceuticals, Inc. Marshall Pharmacal Corp. MD Pharmaceutical, Inc. Medev, Inc. Mission Pharmacal Co. M M Mast & Co. Mutual Pharmaceutical Company, Inc. Newtron Pharmaceuticals, Inc. Novartis Pharmaceuticals Corp. Nylos Trading Co., Inc. Panray Corp Subsidiary of Ormont Drug and Chemical Co., Inc. Parke Davis Division of Warner Lambert Co. Pasadena Research Laboratories, Inc. Penick Corp. Person and Covey, Inc. Pfizer Co. Pfizer, Inc. Pharmaceutical Associates, Inc. Pharmacia and Upjohn Co. Pharmadyne Laboratories, Inc. Pharmavite Pharmaceuticals Phoenix Laboratories, Inc. Polfa Pharmaceutical Works Premo Pharmaceutical Laboratories, Inc. Purepac Pharmaceutical Co. Rachelle Laboratories Italia SpA Reed and Carnrick Division of Block Drug Co., Inc. Rexar Pharmacal Richlyn Laboratories, Inc. Robinson Laboratories, Inc. Roussel Corp. Rovers Pharmacal, Inc. RP Scherer Corp. Sandoz, Inc. Scherer Laboratories, Inc. Schering Corp. Subsidiary of Schering Plough Corp. Smith Kline and French Laboratory Co. Subsidiary of SmithKline Beckman Societa Italiana Prodotti Schering Sperti Drug Products, Inc. Stayner Corp. Steri Med, Inc. Subsidiary of Ketchum Laboratories, Inc. Tablicaps, Inc. Tera Pharmaceuticals, Inc. Teva Pharmaceuticals USA, Inc. Titan Pharmacal, Co. Travenol Laboratories, Inc. Valeant Pharmaceuticals International Watson Laboratories, Inc. Western Research Laboratories, Inc. West-Ward Pharmaceutical Corp. Wharton Laboratories, Inc., Division of US Ethicals Whiteworth Towne Paulsen, Inc. Wyeth Ayerst Laboratories Zenith Laboratories, Inc. TABLE 1—ABBREVIATED NEW DRUG APPLICATION (ANDA) NUMBERS WITH PRODUCT NAMES pmangrum on DSK3VPTVN1PROD with NOTICES ANDA No. 60881 60913 60919 60965 61046 61091 61093 61097 61099 61102 61114 61116 61117 61118 61119 61120 61121 61142 61144 61145 61152 61170 61171 61191 61192 61194 61197 61382 61420 61422 61423 61428 61429 61430 61431 61432 61433 61440 61442 61556 61564 61565 61570 Product name ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 Tetracycline hydrochloride. Dicloxacillin sodium. Neomycin sulfate; bacitracin. Neomycin sulfate; polymyxin b sulfates; bacitracin. Penicillin g sodium. Phenethicillin potassium. Penicillin g potassium. Troleandomycin. Doxycycline hyclate. Oxytetracycline calcium. Chlortetracycline hydrochloride. Ampicillin trihydrate. Phenethicillin potassium. Cloxacillin sodium. Dicloxacillin sodium. Tetracycline. Tetracycline phosphate. Penicillin g potassium. Amphotericin b. Penicillin g potassium. Tetracycline hydrochloride. Bacitracin. Bacitracin zinc. Tetracycline hydrochloride. Tetracycline hydrochloride. Paromomycin sulfate. Tetracycline hydrochloride. Ampicillin trihydrate. Tetracycline. Oxytetracycline hydrochloride. Oxytetracycline. Chloramphenicol palmitate. Tetracycline. Chloramphenicol. Chloramphenicol. Chloramphenicol sodium succinate. Chloramphenicol sodium succinate. Tetracycline hydrochloride. Erythromycin estolate. Tetracycline. Methacycline hydrochloride. Paromomycin sulfate. Hetacillin. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 35693 E:\FR\FM\14JNN1.SGM 14JNN1 35694 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—ABBREVIATED NEW DRUG APPLICATION (ANDA) NUMBERS WITH PRODUCT NAMES—Continued pmangrum on DSK3VPTVN1PROD with NOTICES ANDA No. 61581 61582 61597 61604 61608 61629 61630 61631 61749 61750 61751 61754 61775 61777 61778 61779 61784 61795 61796 61797 61804 61824 61825 61843 61844 61845 61852 61993 62016 62019 62020 62344 80004 80088 80200 80313 80350 80351 80359 80452 80456 80501 80559 80560 80561 80616 80676 80840 80943 80947 80956 80985 83002 83003 83004 83005 83006 83007 83114 83133 83134 83197 83203 83208 83233 83243 83258 83259 83268 83269 83293 83311 Product name ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 Tetracycline hydrochloride. Tetracycline. Ampicillin trihydrate. Ampicillin sodium. Tetracycline hydrochloride. Penicillin g benzathine. Streptomycin sulfate. Dihydrostreptomycin sulfate. Dicloxacillin sodium. Ampicillin trihydrate. Doxycycline hyclate. Griseofulvin. Tetracycline. Mitomycin. Erythromycin. Erythromycin stearate. Tetracycline hydrochloride. Oxacillin sodium. Oxacillin sodium. Methicillin sodium. Carbenicillin indanyl sodium. Tetracycline. Tetracycline. Penicillin v potassium. Ampicillin. Ampicillin trihydrate. Tetracycline phosphate complex. Cloxacillin sodium. Amoxicillin trihydrate. Tetracycline hydrochloride. Tetracycline phosphate. Cloxacillin sodium. Propylthiouracil. Sulfadiazine. Succinylcholine chloride. Methyltestosterone. Prednisone. Prednisolone. Prednisone. Hydrocortisone. Hydrocortisone. Diphenhydramine hydrochloride. Cyanocobalamin. Pyridoxine hydrochloride. Thiamine hydrochloride. Cyanocobalamin. Testosterone propionate. Propylthiouracil. Vitamin a palmitate. Aminosalicylate sodium. Vitamin d. Vitamin a. Diethylstilbestrol. Diethylstilbestrol. Diethylstilbestrol. Diethylstilbestrol. Diethylstilbestrol. Diethylstilbestrol. Vitamin a palmitate. Folic acid. Vitamin a. Propoxyphene hydrochloride. Niacin. Cortisone acetate. Hydrocortisone acetate. Chlorpheniramine maleate. Butabarbital sodium. Pentobarbital sodium. Butabarbital sodium. Butabarbital sodium. Propoxyphene hydrochloride. Vitamin a palmitate. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—ABBREVIATED NEW DRUG APPLICATION (ANDA) NUMBERS WITH PRODUCT NAMES—Continued pmangrum on DSK3VPTVN1PROD with NOTICES ANDA No. 83321 83335 83343 83374 83394 83421 83439 83444 83454 83494 83503 83537 83553 83562 83578 83674 83675 83676 83756 83772 83864 83865 83867 83880 83912 83926 83929 83940 83958 83960 83974 84008 84009 84016 84027 84073 84080 84097 84237 84257 84262 84263 84293 84298 84311 84365 84382 84410 84428 84459 84485 84552 84559 84632 84670 84671 84672 84695 84736 84846 84856 84871 84906 84979 85033 85115 85170 85174 85185 85207 85242 85258 Product name ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 Vitamin a palmitate. Prednisolone acetate. Meprobamate. Estrogens, esterified. Chlorpheniramine maleate. Probenecid. Quinidine sulfate. Rauwolfia serpentina. Lidocaine. Meprobamate. Negatol. Secobarbital sodium. Procainamide hydrochloride. Prednisolone acetate. Butabarbital sodium. Diphenhydramine hydrochloride. Prednisolone. Prednisone. Piperazine citrate. Pyridoxine hydrochloride. Secobarbital sodium. Promethazine hydrochloride. Rauwolfia serpentina. Propoxyphene hydrochloride. Vitamin a palmitate. Ergotamine tartrate; caffeine. Cortisone acetate. Diethylstilbestrol. Propylthiouracil. Prednisolone. Trihexyphenidyl hydrochloride. Chlorpheniramine maleate. Prednisone. Dextroamphetamine hydrochloride. Promethazine hydrochloride. Benzthiazide. Promethazine hydrochloride. Dicyclomine hydrochloride. Niacin. Dicyclomine hydrochloride. Phenylbutazone. Dimenhydrinate. Dicyclomine hydrochloride. Hydrochlorothiazide. Phenylbutazone. Dexamethasone sodium phosphate. Meclizine hydrochloride. Trichlormethiazide. Propantheline bromide. Propylthiouracil. Phentermine hydrochloride. Aminophylline. Theophylline. Aminophylline. Chlordiazepoxide. Chlordiazepoxide. Chlordiazepoxide. Phentermine hydrochloride. Rescinnamine. Methocarbamol. Cortisone acetate. Prednisolone acetate. Reserpine; hydrochlorothiazide. Hydrocortisone. Methocarbamol. Prednisone. Prednisolone. Cortisone acetate. Diethylpropion hydrochloride. Reserpine. Chlordiazepoxide hydrochloride. Chlordiazepoxide. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1 35695 35696 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—ABBREVIATED NEW DRUG APPLICATION (ANDA) NUMBERS WITH PRODUCT NAMES—Continued pmangrum on DSK3VPTVN1PROD with NOTICES ANDA No. 85259 85270 85280 85281 85308 85325 85360 85405 85412 85419 85439 85442 85489 85516 85576 85590 85592 85613 85647 85649 85678 85680 85696 85707 85716 85717 85725 85730 85731 85760 85774 85776 85806 85807 85808 85812 85901 85918 85942 85943 85946 85947 85948 85949 85950 85954 85955 85972 86068 86111 86115 86125 86128 86131 86207 86211 86253 86254 86279 86286 86288 86316 86317 86318 86319 86320 86321 86322 86324 86326 86327 86334 Product name ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 Chlordiazepoxide. Methyltestosterone. Chlordiazepoxide hydrochloride. Chlordiazepoxide hydrochloride. Phenytoin sodium. Methylprednisolone. Chlordiazepoxide hydrochloride. Perphenazine. Tripelennamine hydrochloride. Quinidine sulfate. Butalbital; aspirin; phenacetin; caffeine. Chlordiazepoxide hydrochloride. Probenecid. Theophylline. Estradiol. Oxyphenbutazone. Brompheniramine maleate. Phendimetrazine tartrate. Amitriptyline hydrochloride. Amitriptyline hydrochloride. Amitriptyline hydrochloride. Amitriptyline hydrochloride. Isoniazid; pyridoxine hydrochloride. Isopropamide iodide. Hydralazine hydrochloride. Hydralazine hydrochloride. Phendimetrazine tartrate. Cyanocobalamin. Phentermine hydrochloride. Chlorothiazide. Methyltestosterone. Methyltestosterone. Reserpine; hydralazine hydrochloride; hydrochlorotiazide. Meclizine hydrochloride. Meclizine hydrochloride. Propoxyphene hydrochloride. Imipramine hydrochloride. Ergotamine tartrate; caffeine. Amitriptyline hydrochloride. Triamcinolone acetonide. Amitriptyline hydrochloride. Amitriptyline hydrochloride. Amitriptyline hydrochloride. Amitriptyline hydrochloride. Amitriptyline hydrochloride. Methyltestosterone. Methyltestosterone. Acetaminophen; salicylamide; caffeine; codeine phosphate. Triamcinolone acetonide. Amodiaquine hydrochloride. Bethanechol chloride. Quinidine sulfate. Chlorpromazine. Acetazolamide. Hydrocortisone acetate. Phendimetrazine tartrate. Trihexyphenidyl hydrochloride. Chlorothiazide. Hydrochlorothiazide. Butalbital; aspirin; phenacetin; caffeine. Amitriptyline hydrochloride. Orphenadrine citrate. Diphenoxylate hydrochloride; atropine sulfate. Hydrochlorothiazide. Hydrochlorothiazide. Methocarbamol. Methocarbamol. Prednisone. Prednisone. Butalbital; aspirin; phenacetin; caffeine. Trifluoperazine hydrochloride. Hydrocortisone. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—ABBREVIATED NEW DRUG APPLICATION (ANDA) NUMBERS WITH PRODUCT NAMES—Continued pmangrum on DSK3VPTVN1PROD with NOTICES ANDA No. 86343 86345 86354 86377 86400 86401 86404 86407 86411 86412 86430 86431 86436 86437 86438 86443 86447 86476 86510 86515 86529 86555 86563 86564 86565 86566 86581 86591 86625 86627 86629 86630 86634 86644 86647 86650 86654 86655 86657 86658 86665 86667 86668 86669 86670 86671 86674 86675 86685 86687 86692 86694 86696 86701 86703 86704 86706 86708 86709 86721 86770 86773 86774 86775 86776 86777 86779 86782 86783 86784 86785 86786 Product name ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 Thioridazine hydrochloride. Thioridazine hydrochloride. Thioridazine hydrochloride. Hydrochlorothiazide. Hydrocortisone acetate. Hydrocortisone acetate. Phendimetrazine tartrate. Phendimetrazine tartrate. Dimenhydrinate. Dicyclomine hydrochloride. Phendimetrazine;adipic acid. Phendimetrazine. Homatropine methylbromide. Homatropine hydrobromide. Trifluoperazine hydrochloride. Trifluoperazine hydrochloride. Trifluoperazine hydrochloride. Diazepam. Phentermine hydrochloride. Phentermine hydrochloride. Dicyclomine hydrochloride; phenobarbital. Phendimetrazine tartrate. Dicyclomine hydrochloride; phenobarbital. Phenobarbital; atropine sulfate; hyoscyamine sulfate; hyscyamine hydrobromide. Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. Dicyclomine hydrochloride; phenobarbital. Chlordiazepoxide hydrochloride; clidinium bromide. Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. Dicyclomine hydrochloride. Meprobamate; tridihexethyl chloride. Meprobamate; tridihexethyl chloride. Piperidolate hydrochloride; phenobarbital. Chlordiazepoxide hydrochloride; clidinium bromide. Piperidolate hydrochloride. Chlordiazepoxide hydrochloride; clidinium bromide. Anisotropine methylbromide; phenobarbital. Meprobamate; tridihexethyl chloride. Atropine sulfate; hyoscyamine sulfate; phenobarbital; scopolamine hydrobromide. Phenobarbital; atropine sulfate; hyoscyamine sulfate; scopolamine hydrobromide. Meprobamate; tridihexethyl chloride. Phenobarbital; atropine sulfate; hyoscyamine sulfate; scopolamine hydrobromide. Chlordiazepoxide hydrochloride; clidinium bromide. Phenobarbital; belladonna alkaloid malates, l-. Dicyclomine hydrochloride. Atropine sulfate; hyoscyamine sulfate; phenobarbital; scopolamine hydrobromide. Phenobarbital; hyoscyamine sulfate. Meprobamate; tridihexethyl chloride. Butabarbital sodium; simethicone; atropine sulfate; hyoscyamine sulfate; scopoamine. Chlordiazepoxide hydrochloride; clidinium bromide. Phenobarbital; belladonna extract. Amobarbital; belladonna. Oxyphencyclimine hydrochloride; phenobarbital. Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. Atropine sulfate; phenobarbital. Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. Meprobamate; tridihexethyl chloride. Cyproheptadine hydrochloride. Meprobamate; tridihexethyl chloride. Procainamide hydrochloride. Nitroglycerin. Triamcinolone diacetate. Erythrityl tetranitrate. Isosorbide dinitrate. Pentaerythritol tetranitrate. Nitroglycerin. Nitroglycerin. Nitroglycerin. Isosorbide dinitrate. Pentaerythritol tetranitrate. Pentaerythritol tetranitrate. Isosorbide dinitrate. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1 35697 35698 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—ABBREVIATED NEW DRUG APPLICATION (ANDA) NUMBERS WITH PRODUCT NAMES—Continued ANDA No. 86789 86794 86799 86838 86839 86868 86882 86897 86921 86970 86976 86991 86999 87000 87041 87064 87069 87096 87097 87098 87099 87106 87112 87116 87123 87124 87125 87134 87166 87172 87198 87379 87443 Product name ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ Estradiol valerate. Dipyridamole. Atropine sulfate; phenobarbital. Pentaerythritol tetranitrate. Isosorbide dinitrate. Chlorpromazine hydrochloride. Hydrocortisone. Phenobarbital; hyoscyamine hydrobromide; atropine sulfate; scopolamine hydrobromide. Chlordiazepoxide hydrochloride; clidinum bromide. Aminophylline. Doxylamine succinate; pyridoxine hydrochloride. Probenecid. Butalbital; aspirin; phenacetin; caffeine. Hydralazine hydrochloride. Phendimetrazine tartrate. Piperazine citrate. Sulfisoxazole acetyl. Phentermine hydrochloride. Phentermine hydrochloride. Phentermine hydrochloride. Phentermine hydrochloride. Ergotamine tartrate; caffeine. Spironolactone. Reserpine; chlorothiazide. Benzthiazide. Benzthiazide. Diphenhydramine hydrochloride. Promethazine hydrochloride. Phentolamine hydrochloride. Theophylline. Belladonna alkaloid malates, l-; phenobarbital. Quinidine gluconate. Homatropine methylbromide; phenobarbital. Dated: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. Authority: Section 1111 of the Public Health Service (PHS) Act, 42 U.S.C. 300b–10, as amended. The SACHDNC also is governed by the provisions of Public Law 92–463, as amended (5 U.S.C. App. 2), and 41 CFR part 102–3, which sets forth standards for the formation and use of advisory committees. [FR Doc. 2012–14476 Filed 6–13–12; 8:45 am] BILLING CODE 4160–01–P Health Resources and Services Administration Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). AGENCY: Notice of Request for Nominations of Non-Voting Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) members to serve as representatives of organizations or interest groups. pmangrum on DSK3VPTVN1PROD with NOTICES ACTION: HRSA is requesting applications to fill three (3) vacancies for non-voting organizational representatives on the SACHDNC. SUMMARY: VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 The agency must receive written applications from nominees (including a letter of support from an appropriate official of the organization with which affiliated) or the nominee’s organization, on or before August 1, 2012. ADDRESSES: Submit written applications to Sara Copeland, M.D., Designated Federal Official (DFO), SACHDNC; and, Chief, Genetic Services Branch, Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18A–19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Applications may also be sent to Screening@hrsa.hhs.gov. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Debi Sarkar, M.P.H., Genetic Services Branch, Maternal and Child Health Bureau, HRSA, at dsarkar@hrsa.gov or (301) 443–1080. A copy of the SACHDNC Charter and list of the current membership may be obtained by contacting Ms. Sarkar or by accessing FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 the SACHDNC Web site at https:// www.hrsa.gov/advisorycommittees/ mchbadvisory/heritabledisorders/. SUPPLEMENTARY INFORMATION: The SACHDNC is directed to review and report regularly on newborn and childhood screening practices for heritable disorders and recommend improvements in the national newborn and childhood heritable screening programs. The SACHDNC provides the Secretary with recommendations, advice, and technical information regarding the application of technologies, policies, guidelines, and standards for: (a) Effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders; and (b) enhancing the ability of the State and local health agencies to provide for newborn and child screening, counseling, and health care services for newborns and children having, or at risk for, heritable disorders. Specifically, HRSA is requesting applications for three (3) non-voting organizational representatives to serve on the SACHDNC: Two (2) at large representatives of a public health constituency, medical professional E:\FR\FM\14JNN1.SGM 14JNN1

Agencies

[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35691-35698]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14476]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0517]


Notice of Withdrawal of Certain Unapproved Abbreviated New Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing its intention to deem to be withdrawn any abbreviated new 
drug applications (ANDAs) that have been determined to be incomplete 
and as to which the ANDA applicant has not communicated with FDA since 
July 8, 1991. Each of these applications will be

[[Page 35692]]

deemed to have been withdrawn voluntarily by the applicant unless the 
applicant informs the Agency in writing that it intends to actively 
pursue approval of the application(s) (see DATES).

DATES: The applicant of an ANDA covered by this notice that intends to 
actively pursue approval of its application must submit a written 
notification to FDA by August 13, 2012.

ADDRESSES: Applicants should submit written notifications to the ANDA 
archival file to the Office of Generic Drugs, Center for Drug 
Evaluation and Research, Food and Drug Administration, Document Control 
Room, MPN7, 7620 Standish Pl., Rockville, MD 20855. A copy of written 
notifications should also be submitted to Thomas Hinchliffe, Center for 
Drug Evaluation and Research (HFD-617), Food and Drug Administration, 
7500 Standish Pl., rm. N-142, MPN2, Rockville, MD 20855, FAX: 240-276-
8440, email: inactiveandas@fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Thomas Hinchliffe, Center for Drug 
Evaluation and Research (HFD-617), Food and Drug Administration, 7500 
Standish Pl., rm. N-142, MPN2, Rockville, MD 20855, 240-276-8433, FAX: 
240-276-9310, email: inactiveandas@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has identified 364 ANDAs for which FDA has not received any 
communication from the ANDA applicant since July 8, 1991, or earlier 
(Inactive ANDAs). (See section IV of this document for the list of 
Inactive ANDAs). For purposes of this document, the term ``applicant'' 
includes any successor in interest. FDA's regulations provide that the 
Agency will consider withdrawn any application for which the applicant 
has not contacted the Agency about its intention regarding such 
application within 1 year after issuance of a complete response letter 
to the applicant (see 21 CFR 314.110(c)). The Inactive ANDAs, however, 
predate, and consequently are not subject to this regulation. 
Therefore, the Inactive ANDAs have not been deemed withdrawn although 
there has been no communication from the applicants since July 8, 1991, 
or earlier.

II. Withdrawal of Inactive ANDAs

    At this time, the Agency is announcing its intention to deem all 
Inactive ANDAs to have been voluntarily withdrawn by the respective 
applicants as of August 13, 2012, unless the applicant informs the 
Agency in writing by the date set forth under DATES in this document of 
its intent to actively pursue approval of the application. Therefore, 
in the absence of a written notice with respect to an Inactive ANDA by 
the date specified in this notice, the ANDA will be considered to have 
been withdrawn by the applicant. No further notice of the withdrawal of 
Inactive ANDAs will be provided. Withdrawal of an unapproved 
application is without prejudice to resubmission of that application 
(21 CFR 314.65). Because of the length of time that has passed since 
these applications were submitted, FDA strongly recommends that any 
applicant intending to actively pursue approval review the application 
carefully to determine whether it satisfies current ANDA requirements 
(21 CFR part 314).

III. Action by the Applicant

    If the applicant wishes to actively pursue approval of an Inactive 
ANDA and does not wish the application to be deemed by FDA to have been 
voluntarily withdrawn, the applicant must inform the Agency in writing 
within the time specified in this document. Written notice should be 
provided to Thomas Hinchliffe and the Office of Generic Drugs (see 
ADDRESSES).
    FDA also asks any applicant that agrees to consider its application 
to be voluntarily withdrawn to send a written notice to Thomas 
Hinchliffe and the Office of Generic Drugs (see ADDRESSES) to confirm 
that agreement. However, applicants of Inactive ANDAs covered by this 
notice who wish their applications to be withdrawn are not required to 
provide written notice to FDA.

IV. Details About Inactive ANDAs

    Information about the Inactive ANDAs is listed in this section of 
the document. To protect applicant confidentiality, this notice lists 
the application number and drug name for each Inactive ANDA and 
separately lists the name of the applicant as shown in the information 
on file with FDA, without linking identified applicants with specific 
applications or drug names. In some cases, the identified applicants 
may no longer exist as ongoing business entities. If an identified 
applicant is unsure which application(s) belong to it (if any), it may 
contact Thomas Hinchliffe (see FOR FURTHER INFORMATION CONTACT).

Alphabetical List of Abbreviated New Drug Application Applicants

1st Texas Pharmaceuticals, Inc., Subsidiary of Scherer Laboratories 
Inc.
Abraxis Pharmaceutical Products
AH Robins, Co.
Alpharma US Pharmaceuticals Division
Ambix Laboratories Division of Organics Corp America
Ankerfarm SpA
Ankerman SpA
Antibioticos SA
Arcum Pharmaceutical Corp.
Banner Pharmacaps, Inc.
Barr Laboratories, Inc.
Baxter Healthcare Corp.
Beecham Laboratories Division of Beecham Inc.
Beecham SA
Bel Mar Laboratories, Inc.
Biocraft Laboratories, Inc.
Biometric Testing, Inc.
Boots Laboratories, Inc., Division of Boots Pharmaceuticals Inc.
Bristol Laboratories, Inc., Division of Bristol Myers Co.
Bristol Myers Co. International Division
Bristol Myers Industrial Division
Bristol Myers Squibb
Camall Co., Inc.
Carlo Erba SpA
Century Pharmaceuticals, Inc.
Chemibiotic Ireland, Ltd.
Chromalloy Laboratories Division of Chromalloy Pharmaceuticals, Inc.
Clifford Chemical Corp.
CM Bundy Co.
Comatic Laboratories, Inc.
Credo Co.
Delco Chemical Co., Inc.
Dell Laboratories, Inc.
Dermasave Laboratories, Inc.
Dista Products Co. Division of Eli Lilly & Co.
DM Pharmaceuticals, Inc.
Dorasol Laboratories
Dunhall Pharmaceuticals, Inc.
ER Squibb and Sons Pharmaceutical Laboratories
Ersana, Inc., Subsidiary of ER Squibb and Sons
Everylife
Fallek Products Co., Inc.
Farmila Farmaceutica
Faton Pharmaceuticals, Inc.
Fermion Oy
Ferndale Laboratories, Inc.
Fisons Corp.
Forest Laboratories, Inc.
Forest Pharmaceuticals, Inc.
Forrest Laboratories, Inc.
G & W Co.
Glenwood Laboratories, Inc.
Global Pharmaceutical Corp.
Gruppo Lepetit SpA Subsidiary of Merrell Dow Pharmaceuticals, Inc.
Heather Drug Co., Inc.
Herald Pharmacal, Inc.
Hoffmann La Roche, Inc.
ICI Ltd.
Ingram Pharmaceutical Co.
Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc.

[[Page 35693]]

ISF
Kasar Laboratories Division of Kasar Co.
Kasco EFCO Laboratories, Inc., Division of Byk Gulden, Inc.
KV Pharmaceutical, Co.
Lannett Co, Inc.
Lederle Laboratories Division of American Cyanamid Co.
Leiner Health Products, Inc.
Lemmon Co. Subsidiary of Tag Pharmaceutical, Inc.
Life Laboratories, Inc.
Linden Laboratories, Inc., Subsidiary of Chromalloy American Corp.
Luitpold Pharmaceuticals, Inc.
Marshall Pharmacal Corp.
MD Pharmaceutical, Inc.
Medev, Inc.
Mission Pharmacal Co.
M M Mast & Co.
Mutual Pharmaceutical Company, Inc.
Newtron Pharmaceuticals, Inc.
Novartis Pharmaceuticals Corp.
Nylos Trading Co., Inc.
Panray Corp Subsidiary of Ormont Drug and Chemical Co., Inc.
Parke Davis Division of Warner Lambert Co.
Pasadena Research Laboratories, Inc.
Penick Corp.
Person and Covey, Inc.
Pfizer Co.
Pfizer, Inc.
Pharmaceutical Associates, Inc.
Pharmacia and Upjohn Co.
Pharmadyne Laboratories, Inc.
Pharmavite Pharmaceuticals
Phoenix Laboratories, Inc.
Polfa Pharmaceutical Works
Premo Pharmaceutical Laboratories, Inc.
Purepac Pharmaceutical Co.
Rachelle Laboratories Italia SpA
Reed and Carnrick Division of Block Drug Co., Inc.
Rexar Pharmacal
Richlyn Laboratories, Inc.
Robinson Laboratories, Inc.
Roussel Corp.
Rovers Pharmacal, Inc.
RP Scherer Corp.
Sandoz, Inc.
Scherer Laboratories, Inc.
Schering Corp. Subsidiary of Schering Plough Corp.
Smith Kline and French Laboratory Co. Subsidiary of SmithKline Beckman
Societa Italiana Prodotti Schering
Sperti Drug Products, Inc.
Stayner Corp.
Steri Med, Inc. Subsidiary of Ketchum Laboratories, Inc.
Tablicaps, Inc.
Tera Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
Titan Pharmacal, Co.
Travenol Laboratories, Inc.
Valeant Pharmaceuticals International
Watson Laboratories, Inc.
Western Research Laboratories, Inc.
West-Ward Pharmaceutical Corp.
Wharton Laboratories, Inc., Division of US Ethicals
Whiteworth Towne Paulsen, Inc.
Wyeth Ayerst Laboratories
Zenith Laboratories, Inc.

  Table 1--Abbreviated New Drug Application (ANDA) Numbers With Product
                                  Names
------------------------------------------------------------------------
                     ANDA No.                           Product name
------------------------------------------------------------------------
60881.............................................  Tetracycline
                                                     hydrochloride.
60913.............................................  Dicloxacillin
                                                     sodium.
60919.............................................  Neomycin sulfate;
                                                     bacitracin.
60965.............................................  Neomycin sulfate;
                                                     polymyxin b
                                                     sulfates;
                                                     bacitracin.
61046.............................................  Penicillin g sodium.
61091.............................................  Phenethicillin
                                                     potassium.
61093.............................................  Penicillin g
                                                     potassium.
61097.............................................  Troleandomycin.
61099.............................................  Doxycycline hyclate.
61102.............................................  Oxytetracycline
                                                     calcium.
61114.............................................  Chlortetracycline
                                                     hydrochloride.
61116.............................................  Ampicillin
                                                     trihydrate.
61117.............................................  Phenethicillin
                                                     potassium.
61118.............................................  Cloxacillin sodium.
61119.............................................  Dicloxacillin
                                                     sodium.
61120.............................................  Tetracycline.
61121.............................................  Tetracycline
                                                     phosphate.
61142.............................................  Penicillin g
                                                     potassium.
61144.............................................  Amphotericin b.
61145.............................................  Penicillin g
                                                     potassium.
61152.............................................  Tetracycline
                                                     hydrochloride.
61170.............................................  Bacitracin.
61171.............................................  Bacitracin zinc.
61191.............................................  Tetracycline
                                                     hydrochloride.
61192.............................................  Tetracycline
                                                     hydrochloride.
61194.............................................  Paromomycin sulfate.
61197.............................................  Tetracycline
                                                     hydrochloride.
61382.............................................  Ampicillin
                                                     trihydrate.
61420.............................................  Tetracycline.
61422.............................................  Oxytetracycline
                                                     hydrochloride.
61423.............................................  Oxytetracycline.
61428.............................................  Chloramphenicol
                                                     palmitate.
61429.............................................  Tetracycline.
61430.............................................  Chloramphenicol.
61431.............................................  Chloramphenicol.
61432.............................................  Chloramphenicol
                                                     sodium succinate.
61433.............................................  Chloramphenicol
                                                     sodium succinate.
61440.............................................  Tetracycline
                                                     hydrochloride.
61442.............................................  Erythromycin
                                                     estolate.
61556.............................................  Tetracycline.
61564.............................................  Methacycline
                                                     hydrochloride.
61565.............................................  Paromomycin sulfate.
61570.............................................  Hetacillin.

[[Page 35694]]

 
61581.............................................  Tetracycline
                                                     hydrochloride.
61582.............................................  Tetracycline.
61597.............................................  Ampicillin
                                                     trihydrate.
61604.............................................  Ampicillin sodium.
61608.............................................  Tetracycline
                                                     hydrochloride.
61629.............................................  Penicillin g
                                                     benzathine.
61630.............................................  Streptomycin
                                                     sulfate.
61631.............................................  Dihydrostreptomycin
                                                     sulfate.
61749.............................................  Dicloxacillin
                                                     sodium.
61750.............................................  Ampicillin
                                                     trihydrate.
61751.............................................  Doxycycline hyclate.
61754.............................................  Griseofulvin.
61775.............................................  Tetracycline.
61777.............................................  Mitomycin.
61778.............................................  Erythromycin.
61779.............................................  Erythromycin
                                                     stearate.
61784.............................................  Tetracycline
                                                     hydrochloride.
61795.............................................  Oxacillin sodium.
61796.............................................  Oxacillin sodium.
61797.............................................  Methicillin sodium.
61804.............................................  Carbenicillin
                                                     indanyl sodium.
61824.............................................  Tetracycline.
61825.............................................  Tetracycline.
61843.............................................  Penicillin v
                                                     potassium.
61844.............................................  Ampicillin.
61845.............................................  Ampicillin
                                                     trihydrate.
61852.............................................  Tetracycline
                                                     phosphate complex.
61993.............................................  Cloxacillin sodium.
62016.............................................  Amoxicillin
                                                     trihydrate.
62019.............................................  Tetracycline
                                                     hydrochloride.
62020.............................................  Tetracycline
                                                     phosphate.
62344.............................................  Cloxacillin sodium.
80004.............................................  Propylthiouracil.
80088.............................................  Sulfadiazine.
80200.............................................  Succinylcholine
                                                     chloride.
80313.............................................  Methyltestosterone.
80350.............................................  Prednisone.
80351.............................................  Prednisolone.
80359.............................................  Prednisone.
80452.............................................  Hydrocortisone.
80456.............................................  Hydrocortisone.
80501.............................................  Diphenhydramine
                                                     hydrochloride.
80559.............................................  Cyanocobalamin.
80560.............................................  Pyridoxine
                                                     hydrochloride.
80561.............................................  Thiamine
                                                     hydrochloride.
80616.............................................  Cyanocobalamin.
80676.............................................  Testosterone
                                                     propionate.
80840.............................................  Propylthiouracil.
80943.............................................  Vitamin a palmitate.
80947.............................................  Aminosalicylate
                                                     sodium.
80956.............................................  Vitamin d.
80985.............................................  Vitamin a.
83002.............................................  Diethylstilbestrol.
83003.............................................  Diethylstilbestrol.
83004.............................................  Diethylstilbestrol.
83005.............................................  Diethylstilbestrol.
83006.............................................  Diethylstilbestrol.
83007.............................................  Diethylstilbestrol.
83114.............................................  Vitamin a palmitate.
83133.............................................  Folic acid.
83134.............................................  Vitamin a.
83197.............................................  Propoxyphene
                                                     hydrochloride.
83203.............................................  Niacin.
83208.............................................  Cortisone acetate.
83233.............................................  Hydrocortisone
                                                     acetate.
83243.............................................  Chlorpheniramine
                                                     maleate.
83258.............................................  Butabarbital sodium.
83259.............................................  Pentobarbital
                                                     sodium.
83268.............................................  Butabarbital sodium.
83269.............................................  Butabarbital sodium.
83293.............................................  Propoxyphene
                                                     hydrochloride.
83311.............................................  Vitamin a palmitate.

[[Page 35695]]

 
83321.............................................  Vitamin a palmitate.
83335.............................................  Prednisolone
                                                     acetate.
83343.............................................  Meprobamate.
83374.............................................  Estrogens,
                                                     esterified.
83394.............................................  Chlorpheniramine
                                                     maleate.
83421.............................................  Probenecid.
83439.............................................  Quinidine sulfate.
83444.............................................  Rauwolfia
                                                     serpentina.
83454.............................................  Lidocaine.
83494.............................................  Meprobamate.
83503.............................................  Negatol.
83537.............................................  Secobarbital sodium.
83553.............................................  Procainamide
                                                     hydrochloride.
83562.............................................  Prednisolone
                                                     acetate.
83578.............................................  Butabarbital sodium.
83674.............................................  Diphenhydramine
                                                     hydrochloride.
83675.............................................  Prednisolone.
83676.............................................  Prednisone.
83756.............................................  Piperazine citrate.
83772.............................................  Pyridoxine
                                                     hydrochloride.
83864.............................................  Secobarbital sodium.
83865.............................................  Promethazine
                                                     hydrochloride.
83867.............................................  Rauwolfia
                                                     serpentina.
83880.............................................  Propoxyphene
                                                     hydrochloride.
83912.............................................  Vitamin a palmitate.
83926.............................................  Ergotamine tartrate;
                                                     caffeine.
83929.............................................  Cortisone acetate.
83940.............................................  Diethylstilbestrol.
83958.............................................  Propylthiouracil.
83960.............................................  Prednisolone.
83974.............................................  Trihexyphenidyl
                                                     hydrochloride.
84008.............................................  Chlorpheniramine
                                                     maleate.
84009.............................................  Prednisone.
84016.............................................  Dextroamphetamine
                                                     hydrochloride.
84027.............................................  Promethazine
                                                     hydrochloride.
84073.............................................  Benzthiazide.
84080.............................................  Promethazine
                                                     hydrochloride.
84097.............................................  Dicyclomine
                                                     hydrochloride.
84237.............................................  Niacin.
84257.............................................  Dicyclomine
                                                     hydrochloride.
84262.............................................  Phenylbutazone.
84263.............................................  Dimenhydrinate.
84293.............................................  Dicyclomine
                                                     hydrochloride.
84298.............................................  Hydrochlorothiazide.
84311.............................................  Phenylbutazone.
84365.............................................  Dexamethasone sodium
                                                     phosphate.
84382.............................................  Meclizine
                                                     hydrochloride.
84410.............................................  Trichlormethiazide.
84428.............................................  Propantheline
                                                     bromide.
84459.............................................  Propylthiouracil.
84485.............................................  Phentermine
                                                     hydrochloride.
84552.............................................  Aminophylline.
84559.............................................  Theophylline.
84632.............................................  Aminophylline.
84670.............................................  Chlordiazepoxide.
84671.............................................  Chlordiazepoxide.
84672.............................................  Chlordiazepoxide.
84695.............................................  Phentermine
                                                     hydrochloride.
84736.............................................  Rescinnamine.
84846.............................................  Methocarbamol.
84856.............................................  Cortisone acetate.
84871.............................................  Prednisolone
                                                     acetate.
84906.............................................  Reserpine;
                                                     hydrochlorothiazide
                                                     .
84979.............................................  Hydrocortisone.
85033.............................................  Methocarbamol.
85115.............................................  Prednisone.
85170.............................................  Prednisolone.
85174.............................................  Cortisone acetate.
85185.............................................  Diethylpropion
                                                     hydrochloride.
85207.............................................  Reserpine.
85242.............................................  Chlordiazepoxide
                                                     hydrochloride.
85258.............................................  Chlordiazepoxide.

[[Page 35696]]

 
85259.............................................  Chlordiazepoxide.
85270.............................................  Methyltestosterone.
85280.............................................  Chlordiazepoxide
                                                     hydrochloride.
85281.............................................  Chlordiazepoxide
                                                     hydrochloride.
85308.............................................  Phenytoin sodium.
85325.............................................  Methylprednisolone.
85360.............................................  Chlordiazepoxide
                                                     hydrochloride.
85405.............................................  Perphenazine.
85412.............................................  Tripelennamine
                                                     hydrochloride.
85419.............................................  Quinidine sulfate.
85439.............................................  Butalbital; aspirin;
                                                     phenacetin;
                                                     caffeine.
85442.............................................  Chlordiazepoxide
                                                     hydrochloride.
85489.............................................  Probenecid.
85516.............................................  Theophylline.
85576.............................................  Estradiol.
85590.............................................  Oxyphenbutazone.
85592.............................................  Brompheniramine
                                                     maleate.
85613.............................................  Phendimetrazine
                                                     tartrate.
85647.............................................  Amitriptyline
                                                     hydrochloride.
85649.............................................  Amitriptyline
                                                     hydrochloride.
85678.............................................  Amitriptyline
                                                     hydrochloride.
85680.............................................  Amitriptyline
                                                     hydrochloride.
85696.............................................  Isoniazid;
                                                     pyridoxine
                                                     hydrochloride.
85707.............................................  Isopropamide iodide.
85716.............................................  Hydralazine
                                                     hydrochloride.
85717.............................................  Hydralazine
                                                     hydrochloride.
85725.............................................  Phendimetrazine
                                                     tartrate.
85730.............................................  Cyanocobalamin.
85731.............................................  Phentermine
                                                     hydrochloride.
85760.............................................  Chlorothiazide.
85774.............................................  Methyltestosterone.
85776.............................................  Methyltestosterone.
85806.............................................  Reserpine;
                                                     hydralazine
                                                     hydrochloride;
                                                     hydrochlorotiazide.
85807.............................................  Meclizine
                                                     hydrochloride.
85808.............................................  Meclizine
                                                     hydrochloride.
85812.............................................  Propoxyphene
                                                     hydrochloride.
85901.............................................  Imipramine
                                                     hydrochloride.
85918.............................................  Ergotamine tartrate;
                                                     caffeine.
85942.............................................  Amitriptyline
                                                     hydrochloride.
85943.............................................  Triamcinolone
                                                     acetonide.
85946.............................................  Amitriptyline
                                                     hydrochloride.
85947.............................................  Amitriptyline
                                                     hydrochloride.
85948.............................................  Amitriptyline
                                                     hydrochloride.
85949.............................................  Amitriptyline
                                                     hydrochloride.
85950.............................................  Amitriptyline
                                                     hydrochloride.
85954.............................................  Methyltestosterone.
85955.............................................  Methyltestosterone.
85972.............................................  Acetaminophen;
                                                     salicylamide;
                                                     caffeine; codeine
                                                     phosphate.
86068.............................................  Triamcinolone
                                                     acetonide.
86111.............................................  Amodiaquine
                                                     hydrochloride.
86115.............................................  Bethanechol
                                                     chloride.
86125.............................................  Quinidine sulfate.
86128.............................................  Chlorpromazine.
86131.............................................  Acetazolamide.
86207.............................................  Hydrocortisone
                                                     acetate.
86211.............................................  Phendimetrazine
                                                     tartrate.
86253.............................................  Trihexyphenidyl
                                                     hydrochloride.
86254.............................................  Chlorothiazide.
86279.............................................  Hydrochlorothiazide.
86286.............................................  Butalbital; aspirin;
                                                     phenacetin;
                                                     caffeine.
86288.............................................  Amitriptyline
                                                     hydrochloride.
86316.............................................  Orphenadrine
                                                     citrate.
86317.............................................  Diphenoxylate
                                                     hydrochloride;
                                                     atropine sulfate.
86318.............................................  Hydrochlorothiazide.
86319.............................................  Hydrochlorothiazide.
86320.............................................  Methocarbamol.
86321.............................................  Methocarbamol.
86322.............................................  Prednisone.
86324.............................................  Prednisone.
86326.............................................  Butalbital; aspirin;
                                                     phenacetin;
                                                     caffeine.
86327.............................................  Trifluoperazine
                                                     hydrochloride.
86334.............................................  Hydrocortisone.

[[Page 35697]]

 
86343.............................................  Thioridazine
                                                     hydrochloride.
86345.............................................  Thioridazine
                                                     hydrochloride.
86354.............................................  Thioridazine
                                                     hydrochloride.
86377.............................................  Hydrochlorothiazide.
86400.............................................  Hydrocortisone
                                                     acetate.
86401.............................................  Hydrocortisone
                                                     acetate.
86404.............................................  Phendimetrazine
                                                     tartrate.
86407.............................................  Phendimetrazine
                                                     tartrate.
86411.............................................  Dimenhydrinate.
86412.............................................  Dicyclomine
                                                     hydrochloride.
86430.............................................  Phendimetrazine;adip
                                                     ic acid.
86431.............................................  Phendimetrazine.
86436.............................................  Homatropine
                                                     methylbromide.
86437.............................................  Homatropine
                                                     hydrobromide.
86438.............................................  Trifluoperazine
                                                     hydrochloride.
86443.............................................  Trifluoperazine
                                                     hydrochloride.
86447.............................................  Trifluoperazine
                                                     hydrochloride.
86476.............................................  Diazepam.
86510.............................................  Phentermine
                                                     hydrochloride.
86515.............................................  Phentermine
                                                     hydrochloride.
86529.............................................  Dicyclomine
                                                     hydrochloride;
                                                     phenobarbital.
86555.............................................  Phendimetrazine
                                                     tartrate.
86563.............................................  Dicyclomine
                                                     hydrochloride;
                                                     phenobarbital.
86564.............................................  Phenobarbital;
                                                     atropine sulfate;
                                                     hyoscyamine
                                                     sulfate; hyscyamine
                                                     hydrobromide.
86565.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86566.............................................  Dicyclomine
                                                     hydrochloride;
                                                     phenobarbital.
86581.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86591.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86625.............................................  Dicyclomine
                                                     hydrochloride.
86627.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86629.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86630.............................................  Piperidolate
                                                     hydrochloride;
                                                     phenobarbital.
86634.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86644.............................................  Piperidolate
                                                     hydrochloride.
86647.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86650.............................................  Anisotropine
                                                     methylbromide;
                                                     phenobarbital.
86654.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86655.............................................  Atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     phenobarbital;
                                                     scopolamine
                                                     hydrobromide.
86657.............................................  Phenobarbital;
                                                     atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86658.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86665.............................................  Phenobarbital;
                                                     atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86667.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86668.............................................  Phenobarbital;
                                                     belladonna alkaloid
                                                     malates, l-.
86669.............................................  Dicyclomine
                                                     hydrochloride.
86670.............................................  Atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     phenobarbital;
                                                     scopolamine
                                                     hydrobromide.
86671.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate.
86674.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86675.............................................  Butabarbital sodium;
                                                     simethicone;
                                                     atropine sulfate;
                                                     hyoscyamine
                                                     sulfate;
                                                     scopoamine.
86685.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinium bromide.
86687.............................................  Phenobarbital;
                                                     belladonna extract.
86692.............................................  Amobarbital;
                                                     belladonna.
86694.............................................  Oxyphencyclimine
                                                     hydrochloride;
                                                     phenobarbital.
86696.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86701.............................................  Atropine sulfate;
                                                     phenobarbital.
86703.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86704.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     sulfate; atropine
                                                     sulfate;
                                                     scopolamine
                                                     hydrobromide.
86706.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86708.............................................  Cyproheptadine
                                                     hydrochloride.
86709.............................................  Meprobamate;
                                                     tridihexethyl
                                                     chloride.
86721.............................................  Procainamide
                                                     hydrochloride.
86770.............................................  Nitroglycerin.
86773.............................................  Triamcinolone
                                                     diacetate.
86774.............................................  Erythrityl
                                                     tetranitrate.
86775.............................................  Isosorbide
                                                     dinitrate.
86776.............................................  Pentaerythritol
                                                     tetranitrate.
86777.............................................  Nitroglycerin.
86779.............................................  Nitroglycerin.
86782.............................................  Nitroglycerin.
86783.............................................  Isosorbide
                                                     dinitrate.
86784.............................................  Pentaerythritol
                                                     tetranitrate.
86785.............................................  Pentaerythritol
                                                     tetranitrate.
86786.............................................  Isosorbide
                                                     dinitrate.

[[Page 35698]]

 
86789.............................................  Estradiol valerate.
86794.............................................  Dipyridamole.
86799.............................................  Atropine sulfate;
                                                     phenobarbital.
86838.............................................  Pentaerythritol
                                                     tetranitrate.
86839.............................................  Isosorbide
                                                     dinitrate.
86868.............................................  Chlorpromazine
                                                     hydrochloride.
86882.............................................  Hydrocortisone.
86897.............................................  Phenobarbital;
                                                     hyoscyamine
                                                     hydrobromide;
                                                     atropine sulfate;
                                                     scopolamine
                                                     hydrobromide.
86921.............................................  Chlordiazepoxide
                                                     hydrochloride;
                                                     clidinum bromide.
86970.............................................  Aminophylline.
86976.............................................  Doxylamine
                                                     succinate;
                                                     pyridoxine
                                                     hydrochloride.
86991.............................................  Probenecid.
86999.............................................  Butalbital; aspirin;
                                                     phenacetin;
                                                     caffeine.
87000.............................................  Hydralazine
                                                     hydrochloride.
87041.............................................  Phendimetrazine
                                                     tartrate.
87064.............................................  Piperazine citrate.
87069.............................................  Sulfisoxazole
                                                     acetyl.
87096.............................................  Phentermine
                                                     hydrochloride.
87097.............................................  Phentermine
                                                     hydrochloride.
87098.............................................  Phentermine
                                                     hydrochloride.
87099.............................................  Phentermine
                                                     hydrochloride.
87106.............................................  Ergotamine tartrate;
                                                     caffeine.
87112.............................................  Spironolactone.
87116.............................................  Reserpine;
                                                     chlorothiazide.
87123.............................................  Benzthiazide.
87124.............................................  Benzthiazide.
87125.............................................  Diphenhydramine
                                                     hydrochloride.
87134.............................................  Promethazine
                                                     hydrochloride.
87166.............................................  Phentolamine
                                                     hydrochloride.
87172.............................................  Theophylline.
87198.............................................  Belladonna alkaloid
                                                     malates, l-;
                                                     phenobarbital.
87379.............................................  Quinidine gluconate.
87443.............................................  Homatropine
                                                     methylbromide;
                                                     phenobarbital.
------------------------------------------------------------------------


    Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14476 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P

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