Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications, 42455-42458 [2010-17785]

Download as PDF Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Notices or her records or otherwise provide enough information to enable the identification of the individual’s record; (3) identify the information that the individual believes is not accurate, relevant, timely or complete; (4) indicate what corrective action is sought; and (5) include supporting justification or documentation for the requested amendment. Verification of identity as described in the Department’s Privacy Act regulations may be required. 45 CFR 5b.5. RECORD SOURCE CATEGORIES: Information is obtained from individuals and organizations, including third parties conducting business on behalf of a business or organization, that apply for access privileges to the FPLS Child Support Services Portal and its services. Prevention, Department of Health and Human Services, has been renewed for a 2-year period through June 30, 2012. FOR FURTHER INFORMATION CONTACT: Price Connor, PhD, Executive Secretary, Safety and Occupational Health Study Section, Department of Health and Human Services, 1600 Clifton Road, NE., Mailstop E74, Atlanta, Georgia 30333, telephone 404/498–2511 or fax 404/498–2571. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: July 13, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. EXEMPTIONS CLAIMED FOR THE SYSTEM: None. [FR Doc. 2010–17738 Filed 7–20–10; 8:45 am] [FR Doc. 2010–17759 Filed 7–20–10; 8:45 am] BILLING CODE 4184–42–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration Safety and Occupational Health Study Section: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92– 463) of October 6, 1972, that the Safety and Occupational Health Study Section, Centers for Disease Control and [Docket No. FDA–2010–N–0318] Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications AGENCY: ACTION: 42455 Notice. The Food and Drug Administration (FDA) is withdrawing approval of 27 new drug applications (NDAs) and 58 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: DATES: Effective Date: August 20, 2010. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993–0002, 301– 796–3601. The holders of the applications listed in table 1 of this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications pursuant to the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Food and Drug Administration, HHS. TABLE 1. Application No. Drug Applicant Mesantoin (mephenytoin) Tablets Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936–1080 NDA 9–000 Cafergot (ergotamine tartrate and caffeine) Suppository, 1 milligram (mg)/100 mg and 2 mg/100 mg Do. NDA 9–561 Hypaque (diatrizoate sodium) GE Healthcare, Inc., 101 Carnegie Center, Princeton, NJ 08540 NDA 9–658 Hydrocortisone Tablets Smith, Miller and Patch, Inc., Division of Cooper Vision, Inc., c/o Cooper Laboratories, Inc., 455 E. Middlefied Rd., Mountain View, CA 94043 NDA 9–942 Deltra (prednisone) Tablets Merck & Co., Inc., P.O. Box 4, BLA–20, West Point, PA 19486–0004 NDA 10–051 erowe on DSKG8SOYB1PROD with NOTICES NDA 6–008 Hydeltra (prednisolone) Tablets Do. NDA 10–255 Meticortelone (prednisolone acetate) Injection and Suspension Schering Corp., Galloping Hill Rd., Kenilworth, NJ 07033 NDA 12–885 Winstrol (stanozolol) Tablets, 2 mg Lundbeck, Inc., Four Parkway North, Deerfield, IL 60015 NDA 13–428 Valpin (anisotropine methylbromide) Tablets Endo Pharmaceuticals, 100 Endo Blvd., Chadds Ford, PA 19317 VerDate Mar<15>2010 15:19 Jul 20, 2010 Jkt 220001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1 42456 Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Notices TABLE 1.—Continued Application No. Drug Applicant Symmetrel (amantadine hydrochloride (HCl) USP) Syrup Do. NDA 16–119 Teslac (testolactone) Injection, 100 mg/milliliter (mL) Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543–4000 NDA 16–403 Hypaque-Cysto (diatrizoate meglumine) and Hypaque (diatrizoate meglumine) GE Healthcare, Inc. NDA 16–636 Narcar (naloxone HCl) Injection Endo Pharmaceuticals NDA 16–769 Urispas (flavoxate HCl) Tablets, 100 mg Ortho-McNeil-Janssen Pharmaceutical, Inc., 1000 U.S. Highway 202, P.O. Box 3000, Raritan, NJ 08869–0602 NDA 17–022 Methotrexate Tablets Lederle Laboratories, A Division of American Cyanamid Co., 401 N. Middletown Rd., Pearl River, NY 10965 NDA 17–118 Symmetrel (amantadine HCl USP) Syrup Endo Pharmaceuticals NDA 17–255 MPI DTPA Chelate multidose (kit for the preparation of technetium Tc-99m pentetate injection) Medi-Physics, Inc., d/b/a GE Healthcare, Inc., 101 Carnegie Center, Princeton, NJ 08540 NDA 17–264 Technetium Tc-99m pentetate kit Do. NDA 17–559 Proventil (albuterol USP) Inhalation Aerosol Schering Corp. NDA 17–984 Valcaps (diazepam) Capsules Hoffmann-LaRoche, Inc., Roche Pharmaceuticals, 340 Kingsland St., Nutley, NJ 07110–1199 NDA 18–101 Symmetrel (amantadine HCl USP) Tablets Endo Pharmaceuticals NDA 18–445 Dolobid (diflunisal) Tablets, 250 mg and 500 mg Merck & Co., Inc. ANDA 18–551 Potassium Iodide Oral Solution USP, 1 gram (g)/mL Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228 NDA 18–706 Hydergine LC (ergoloid mesylates) Capsules Novartis Pharmaceuticals Corp. NDA 18–746 Vasocon-A (antazoline phosphate, 0.5% and naphazoline HCl, 0.05%) Ophthalmic Solution Do. ANDA 18–750 Furosemide Tablets, 40 mg Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893 NDA 19–309 Vasotec (enalaprilat) Injection Biovail Laboratories International SRL, c/o Biovail Technologies Ltd., 700 Route 202/206 North, Bridgewater, NJ 08807 NDA 21–007 Agenerase (amprenavir), 50 mg and 150 mg GlaxoSmithKline, One Franklin Plaza, 200 North 16th St., Philadelphia, PA 19102 NDA 21–039 Agenerase (amprenavir) Oral Solution, 15 mg/mL Do. ANDA 40–149 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/500 mg and 7.5 mg/750 mg Sandoz, Inc. ANDA 40–312 Innofem (estradiol tablets USP), 0.5 mg, 1 mg, and 2 mg Novo Nordisk, Inc., 100 College Rd. West, Princeton, NJ 08540 ANDA 60–568 Urobiotic (oxytetracycline HCl, sulfamethizole, phenazopyridine HCl) Capsules Pfizer Inc., 235 East 42nd St., New York, NY 10017 ANDA 61–016 Terra-Cortril (hydrocortisone acetate and oxytetracycline HCl) Do. ANDA 61–410 Veetids (penicillin V potassium for Oral Solution USP), 125 mg/5 mL and 250 mg/5 mL Apothecon, c/o Bristol-Myers Squibb, P.O. Box 4000, Princeton, NJ 08543 ANDA 61–471 erowe on DSKG8SOYB1PROD with NOTICES NDA 16–023 Tetracycline HCl Capsules, 250 mg Sandoz, Inc. ANDA 61–781 Erythromycin StearateTablets, 250 mg Do. ANDA 61–965 Nystatin Vaginal Tablets, 100,000 Units Do. ANDA 62–014 Oxytetracycline Capsules, 250 mg Do. ANDA 62–065 Nystatin Tablets, 500,000 Units Do. VerDate Mar<15>2010 15:19 Jul 20, 2010 Jkt 220001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1 Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Notices 42457 TABLE 1.—Continued Application No. Drug Applicant Kefurox (cefuroxime for injection USP), 750 mg/vial and 1.5 g/vial Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 ANDA 62–592 Kefurox (cefuroxime for injection USP), 750 mg/vial and 1.5 g/vial Do. ANDA 64–033 Cefazolin Sodium ADD-Vantage Powder for Injection Solution GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101–7929 ANDA 65–210 Clarithromycin Extended-Release Tablets, 1,000 mg Ranbaxy, Inc., U.S. Agent for Ranbaxy Laboratories Limited, 600 College Rd. East, Princeton, NJ 08540 ANDA 73–696 Nitrofurantoin Capsules USP, 25 mg, 50 mg, and 100 mg Watson Laboratories, Inc., P.O. Box 450 39 Mt. Ebo Rd. South, Brewster, NY 10509 ANDA 74–648 Lorazepam Oral Solution, 0.5 mg/5 mL Roxane Laboratories, Inc. ANDA 74–764 Ranitidine Injection USP Bedford Laboratories, A division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146 ANDA 75–170 Butorphanlol Tartrate Injection USP, 1 mg/mL and 2 mg/mL Hospira, Inc., 275 N. Field Dr., Dept. 0389, Bldg. H2, Lake Forest, IL 60045–5046 ANDA 76–027 Tamoxifen Citrate Tablets USP, 10 mg and 20 mg Roxane Laboratories, Inc. ANDA 76–605 Gabapentin Tablets USP, 600 mg and 800 mg Do. ANDA 76–643 Carbidopa and Levodopa Tablets for Oral Suspension, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/ 250 mg Do. ANDA 76–663 Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mg KV Pharmaceutical Co., 2503 South Hanley Rd., St. Louis, MO 63144 ANDA 77–366 Glimepiride Tablets USP, 3 mg and 6 mg Ranbaxy Inc. ANDA 81–096 Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/30 mg Mikart, Inc., 1750 Chattahoochee Ave., NW, Atlanta, GA 30318 ANDA 81–097 Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/60 mg Do. ANDA 81–226 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 5 mg/500 mg/15 mL Do. ANDA 83–902 Dexedrine (dextroamphetamine sulfate), 5 mg/mL GlaxoSmithKline, Research Triangle Park, NC 27709–3398 ANDA 84–353 Bethanechol Chloride Tablets, 5 mg Do. ANDA 84–378 Bethanechol Chloride Tablets, 10 mg (Blue) Do. ANDA 84–379 Bethanechol Chloride Tablets, 10 mg (Pink) Do. ANDA 84–383 Bethanechol Chloride Tablets, 25 mg (Yellow) Do. ANDA 84–384 Bethanechol Chloride Tablets, 25 mg Do. ANDA 84–617 Hydralazine HCl and Reserpine Tablets, 25 mg/0.1 mg Do. ANDA 84–773 Prednisolone Tablets, 5 mg Do. ANDA 84–774 Prednisone Tablets, 5 mg Do. ANDA 84–869 erowe on DSKG8SOYB1PROD with NOTICES ANDA 62–590 Imipramine HCl Tablets, 25 mg Do. ANDA 84–876 Hydrochlorothiazide, Reserpine, and Hydralazine HCl Tablets, 15 mg/0.1 mg/25 mg Do. ANDA 84–935 Dexedrine (dextroamphetamine sulfate) Tablets GlaxoSmithKline, Research Triangle Park, NC 27709–3398 ANDA 84–956 Hydralazine HCl Tablets, 25 mg Sandoz, Inc. VerDate Mar<15>2010 15:19 Jul 20, 2010 Jkt 220001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1 42458 Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Notices TABLE 1.—Continued Application No. Drug Applicant Hydralazine HCl Tablets, 50 mg Do. ANDA 85–146 Promethazine HCl Tablets, 25 mg and 50 mg Do. ANDA 85–934 Butabarbital Sodium Tablets, 30 mg Do. ANDA 85–938 Butabarbital Sodium Tablets, 15 mg Do. ANDA 86–171 Trichlormethiazide Tablets, 4 mg Do. ANDA 86–505 Hypaque-76 (diatrizoate meglumine and diatrizoate sodium injection USP) GE Healthcare, Inc. ANDA 87–118 Chlorthalidone Tablets, 50 mg Sadoz, Inc. ANDA 87–282 Methocarbamol Tablets, 750 mg Do. ANDA 87–283 Methocarbamol Tablets, 500 mg Do. ANDA 87–449 Theophylline Oral Solution, 80 mg/15 mL Roxane Laboratories, Inc. ANDA 87–462 Theophylline Extended-Release Capsules, 260 mg Sandoz, Inc. ANDA 88–157 Chlorpromazine HCl Intensol (chlorpromazine HCl oral concentrate USP), 30 mg/mL Roxane Laboratories, Inc. ANDA 88–158 Chlorpromazine HCl Intensol (chlorpromazine HCl oral concentrate USP), 100 mg/mL Do. ANDA 88–193 Triprolidine HCl and Pseudoephedrine HCl Tablets, 2.5 mg/60 mg Sandoz, Inc. ANDA 88–587 Hydrochlorothiazide Oral Solution Roxane Laboratories, Inc. ANDA 89–127 Mepro-Aspirin (aspirin and meprobamate) Tablets, 325 mg/200 mg Sandoz, Inc. ANDA 89–508 erowe on DSKG8SOYB1PROD with NOTICES ANDA 85–088 Fluorouracil Injection USP, 50 mg/mL Bedford Laboratories Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective August 20, 2010. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 in this document that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. VerDate Mar<15>2010 15:19 Jul 20, 2010 Jkt 220001 Dated: June 15, 2010. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. 2010–17785 Filed 7–20–10; 8:45 am] BILLING CODE 4160–01–S Federal Emergency Management Agency [Internal Agency Docket No. FEMA–1907– DR; Docket ID FEMA–2010–0002] North Dakota; Amendment No. 4 to Notice of a Major Disaster Declaration Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This notice amends the notice of a major disaster declaration for the State of North Dakota (FEMA–1907– DR), dated April 30, 2010, and related determinations. DATES: Effective Date: July 15, 2010. SUMMARY: Frm 00085 Fmt 4703 Peggy Miller, Recovery Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886. Notice is hereby given that the incident period for this disaster is closed effective July 15, 2010. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HOMELAND SECURITY PO 00000 FOR FURTHER INFORMATION CONTACT: Sfmt 4703 The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance— Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance E:\FR\FM\21JYN1.SGM 21JYN1

Agencies

[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Notices]
[Pages 42455-42458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17785]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0318]


Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 
27 New Drug Applications and 58 Abbreviated New Drug Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of 27 new drug applications (NDAs) and 58 abbreviated new drug 
applications (ANDAs) from multiple applicants. The holders of the 
applications notified the agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

DATES: Effective Date: August 20, 2010.

FOR FURTHER INFORMATION CONTACT:  Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
table 1 of this document have informed FDA that these drug products are 
no longer marketed and have requested that FDA withdraw approval of the 
applications pursuant to the process in Sec.  314.150(c) (21 CFR 
314.150(c)). The applicants have also, by their requests, waived their 
opportunity for a hearing. Withdrawal of approval of an application or 
abbreviated application under Sec.  314.150(c) is without prejudice to 
refiling.

                                                    Table 1.
----------------------------------------------------------------------------------------------------------------
     Application No.                       Drug                                      Applicant
----------------------------------------------------------------------------------------------------------------
NDA 6-008                 Mesantoin (mephenytoin) Tablets         Novartis Pharmaceuticals Corp., One Health
                                                                   Plaza, East Hanover, NJ 07936-1080
----------------------------------------------------------------------------------------------------------------
NDA 9-000                 Cafergot (ergotamine tartrate and       Do.
                           caffeine) Suppository, 1 milligram
                           (mg)/100 mg and 2 mg/100 mg
----------------------------------------------------------------------------------------------------------------
NDA 9-561                 Hypaque (diatrizoate sodium)            GE Healthcare, Inc., 101 Carnegie Center,
                                                                   Princeton, NJ 08540
----------------------------------------------------------------------------------------------------------------
NDA 9-658                 Hydrocortisone Tablets                  Smith, Miller and Patch, Inc., Division of
                                                                   Cooper Vision, Inc., c/o Cooper Laboratories,
                                                                   Inc., 455 E. Middlefied Rd., Mountain View,
                                                                   CA 94043
----------------------------------------------------------------------------------------------------------------
NDA 9-942                 Deltra (prednisone) Tablets             Merck & Co., Inc., P.O. Box 4, BLA-20, West
                                                                   Point, PA 19486-0004
----------------------------------------------------------------------------------------------------------------
NDA 10-051                Hydeltra (prednisolone) Tablets         Do.
----------------------------------------------------------------------------------------------------------------
NDA 10-255                Meticortelone (prednisolone acetate)    Schering Corp., Galloping Hill Rd.,
                           Injection and Suspension                Kenilworth, NJ 07033
----------------------------------------------------------------------------------------------------------------
NDA 12-885                Winstrol (stanozolol) Tablets, 2 mg     Lundbeck, Inc., Four Parkway North, Deerfield,
                                                                   IL 60015
----------------------------------------------------------------------------------------------------------------
NDA 13-428                Valpin (anisotropine methylbromide)     Endo Pharmaceuticals, 100 Endo Blvd., Chadds
                           Tablets                                 Ford, PA 19317
----------------------------------------------------------------------------------------------------------------

[[Page 42456]]

 
NDA 16-023                Symmetrel (amantadine hydrochloride     Do.
                           (HCl) USP) Syrup
----------------------------------------------------------------------------------------------------------------
NDA 16-119                Teslac (testolactone) Injection, 100    Bristol-Myers Squibb Co., P.O. Box 4000,
                           mg/milliliter (mL)                      Princeton, NJ 08543-4000
----------------------------------------------------------------------------------------------------------------
NDA 16-403                Hypaque-Cysto (diatrizoate meglumine)   GE Healthcare, Inc.
                           and Hypaque (diatrizoate meglumine)
----------------------------------------------------------------------------------------------------------------
NDA 16-636                Narcar (naloxone HCl) Injection         Endo Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
NDA 16-769                Urispas (flavoxate HCl) Tablets, 100    Ortho-McNeil-Janssen Pharmaceutical, Inc.,
                           mg                                      1000 U.S. Highway 202, P.O. Box 3000,
                                                                   Raritan, NJ 08869-0602
----------------------------------------------------------------------------------------------------------------
NDA 17-022                Methotrexate Tablets                    Lederle Laboratories, A Division of American
                                                                   Cyanamid Co., 401 N. Middletown Rd., Pearl
                                                                   River, NY 10965
----------------------------------------------------------------------------------------------------------------
NDA 17-118                Symmetrel (amantadine HCl USP) Syrup    Endo Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
NDA 17-255                MPI DTPA Chelate multidose (kit for     Medi-Physics, Inc., d/b/a GE Healthcare, Inc.,
                           the preparation of technetium Tc-99m    101 Carnegie Center, Princeton, NJ 08540
                           pentetate injection)
----------------------------------------------------------------------------------------------------------------
NDA 17-264                Technetium Tc-99m pentetate kit         Do.
----------------------------------------------------------------------------------------------------------------
NDA 17-559                Proventil (albuterol USP) Inhalation    Schering Corp.
                           Aerosol
----------------------------------------------------------------------------------------------------------------
NDA 17-984                Valcaps (diazepam) Capsules             Hoffmann-LaRoche, Inc., Roche Pharmaceuticals,
                                                                   340 Kingsland St., Nutley, NJ 07110-1199
----------------------------------------------------------------------------------------------------------------
NDA 18-101                Symmetrel (amantadine HCl USP) Tablets  Endo Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
NDA 18-445                Dolobid (diflunisal) Tablets, 250 mg    Merck & Co., Inc.
                           and 500 mg
----------------------------------------------------------------------------------------------------------------
ANDA 18-551               Potassium Iodide Oral Solution USP, 1   Roxane Laboratories, Inc., 1809 Wilson Rd.,
                           gram (g)/mL                             Columbus, OH 43228
----------------------------------------------------------------------------------------------------------------
NDA 18-706                Hydergine LC (ergoloid mesylates)       Novartis Pharmaceuticals Corp.
                           Capsules
----------------------------------------------------------------------------------------------------------------
NDA 18-746                Vasocon-A (antazoline phosphate, 0.5%   Do.
                           and naphazoline HCl, 0.05%)
                           Ophthalmic Solution
----------------------------------------------------------------------------------------------------------------
ANDA 18-750               Furosemide Tablets, 40 mg               Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC
                                                                   27893
----------------------------------------------------------------------------------------------------------------
NDA 19-309                Vasotec (enalaprilat) Injection         Biovail Laboratories International SRL, c/o
                                                                   Biovail Technologies Ltd., 700 Route 202/206
                                                                   North, Bridgewater, NJ 08807
----------------------------------------------------------------------------------------------------------------
NDA 21-007                Agenerase (amprenavir), 50 mg and 150   GlaxoSmithKline, One Franklin Plaza, 200 North
                           mg                                      16th St., Philadelphia, PA 19102
----------------------------------------------------------------------------------------------------------------
NDA 21-039                Agenerase (amprenavir) Oral Solution,   Do.
                           15 mg/mL
----------------------------------------------------------------------------------------------------------------
ANDA 40-149               Hydrocodone Bitartrate and              Sandoz, Inc.
                           Acetaminophen Tablets USP, 5 mg/500
                           mg and 7.5 mg/750 mg
----------------------------------------------------------------------------------------------------------------
ANDA 40-312               Innofem (estradiol tablets USP), 0.5    Novo Nordisk, Inc., 100 College Rd. West,
                           mg, 1 mg, and 2 mg                      Princeton, NJ 08540
----------------------------------------------------------------------------------------------------------------
ANDA 60-568               Urobiotic (oxytetracycline HCl,         Pfizer Inc., 235 East 42nd St., New York, NY
                           sulfamethizole, phenazopyridine HCl)    10017
                           Capsules
----------------------------------------------------------------------------------------------------------------
ANDA 61-016               Terra-Cortril (hydrocortisone acetate   Do.
                           and oxytetracycline HCl)
----------------------------------------------------------------------------------------------------------------
ANDA 61-410               Veetids (penicillin V potassium for     Apothecon, c/o Bristol-Myers Squibb, P.O. Box
                           Oral Solution USP), 125 mg/5 mL and     4000, Princeton, NJ 08543
                           250 mg/5 mL
----------------------------------------------------------------------------------------------------------------
ANDA 61-471               Tetracycline HCl Capsules, 250 mg       Sandoz, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 61-781               Erythromycin StearateTablets, 250 mg    Do.
----------------------------------------------------------------------------------------------------------------
ANDA 61-965               Nystatin Vaginal Tablets, 100,000       Do.
                           Units
----------------------------------------------------------------------------------------------------------------
ANDA 62-014               Oxytetracycline Capsules, 250 mg        Do.
----------------------------------------------------------------------------------------------------------------
ANDA 62-065               Nystatin Tablets, 500,000 Units         Do.
----------------------------------------------------------------------------------------------------------------

[[Page 42457]]

 
ANDA 62-590               Kefurox (cefuroxime for injection       Eli Lilly & Co., Lilly Corporate Center,
                           USP), 750 mg/vial and 1.5 g/vial        Indianapolis, IN 46285
----------------------------------------------------------------------------------------------------------------
ANDA 62-592               Kefurox (cefuroxime for injection       Do.
                           USP), 750 mg/vial and 1.5 g/vial
----------------------------------------------------------------------------------------------------------------
ANDA 64-033               Cefazolin Sodium ADD-Vantage Powder     GlaxoSmithKline, One Franklin Plaza, P.O. Box
                           for Injection Solution                  7929, Philadelphia, PA 19101-7929
----------------------------------------------------------------------------------------------------------------
ANDA 65-210               Clarithromycin Extended-Release         Ranbaxy, Inc., U.S. Agent for Ranbaxy
                           Tablets, 1,000 mg                       Laboratories Limited, 600 College Rd. East,
                                                                   Princeton, NJ 08540
----------------------------------------------------------------------------------------------------------------
ANDA 73-696               Nitrofurantoin Capsules USP, 25 mg, 50  Watson Laboratories, Inc., P.O. Box 450 39 Mt.
                           mg, and 100 mg                          Ebo Rd. South, Brewster, NY 10509
----------------------------------------------------------------------------------------------------------------
ANDA 74-648               Lorazepam Oral Solution, 0.5 mg/5 mL    Roxane Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 74-764               Ranitidine Injection USP                Bedford Laboratories, A division of Ben Venue
                                                                   Laboratories, Inc., 300 Northfield Rd.,
                                                                   Bedford, OH 44146
----------------------------------------------------------------------------------------------------------------
ANDA 75-170               Butorphanlol Tartrate Injection USP, 1  Hospira, Inc., 275 N. Field Dr., Dept. 0389,
                           mg/mL and 2 mg/mL                       Bldg. H2, Lake Forest, IL 60045-5046
----------------------------------------------------------------------------------------------------------------
ANDA 76-027               Tamoxifen Citrate Tablets USP, 10 mg    Roxane Laboratories, Inc.
                           and 20 mg
----------------------------------------------------------------------------------------------------------------
ANDA 76-605               Gabapentin Tablets USP, 600 mg and 800  Do.
                           mg
----------------------------------------------------------------------------------------------------------------
ANDA 76-643               Carbidopa and Levodopa Tablets for      Do.
                           Oral Suspension, 10 mg/100 mg, 25 mg/
                           100 mg, and 25 mg/250 mg
----------------------------------------------------------------------------------------------------------------
ANDA 76-663               Carbidopa and Levodopa Extended-        KV Pharmaceutical Co., 2503 South Hanley Rd.,
                           Release Tablets, 50 mg/200 mg           St. Louis, MO 63144
----------------------------------------------------------------------------------------------------------------
ANDA 77-366               Glimepiride Tablets USP, 3 mg and 6 mg  Ranbaxy Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 81-096               Acetaminophen, Aspirin, and Codeine     Mikart, Inc., 1750 Chattahoochee Ave., NW,
                           Phosphate Capsules, 150 mg/180 mg/30    Atlanta, GA 30318
                           mg
----------------------------------------------------------------------------------------------------------------
ANDA 81-097               Acetaminophen, Aspirin, and Codeine     Do.
                           Phosphate Capsules, 150 mg/180 mg/60
                           mg
----------------------------------------------------------------------------------------------------------------
ANDA 81-226               Hydrocodone Bitartrate and              Do.
                           Acetaminophen Oral Solution, 5 mg/500
                           mg/15 mL
----------------------------------------------------------------------------------------------------------------
ANDA 83-902               Dexedrine (dextroamphetamine sulfate),  GlaxoSmithKline, Research Triangle Park, NC
                           5 mg/mL                                 27709-3398
----------------------------------------------------------------------------------------------------------------
ANDA 84-353               Bethanechol Chloride Tablets, 5 mg      Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-378               Bethanechol Chloride Tablets, 10 mg     Do.
                           (Blue)
----------------------------------------------------------------------------------------------------------------
ANDA 84-379               Bethanechol Chloride Tablets, 10 mg     Do.
                           (Pink)
----------------------------------------------------------------------------------------------------------------
ANDA 84-383               Bethanechol Chloride Tablets, 25 mg     Do.
                           (Yellow)
----------------------------------------------------------------------------------------------------------------
ANDA 84-384               Bethanechol Chloride Tablets, 25 mg     Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-617               Hydralazine HCl and Reserpine Tablets,  Do.
                           25 mg/0.1 mg
----------------------------------------------------------------------------------------------------------------
ANDA 84-773               Prednisolone Tablets, 5 mg              Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-774               Prednisone Tablets, 5 mg                Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-869               Imipramine HCl Tablets, 25 mg           Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-876               Hydrochlorothiazide, Reserpine, and     Do.
                           Hydralazine HCl Tablets, 15 mg/0.1 mg/
                           25 mg
----------------------------------------------------------------------------------------------------------------
ANDA 84-935               Dexedrine (dextroamphetamine sulfate)   GlaxoSmithKline, Research Triangle Park, NC
                           Tablets                                 27709-3398
----------------------------------------------------------------------------------------------------------------
ANDA 84-956               Hydralazine HCl Tablets, 25 mg          Sandoz, Inc.
----------------------------------------------------------------------------------------------------------------

[[Page 42458]]

 
ANDA 85-088               Hydralazine HCl Tablets, 50 mg          Do.
----------------------------------------------------------------------------------------------------------------
ANDA 85-146               Promethazine HCl Tablets, 25 mg and 50  Do.
                           mg
----------------------------------------------------------------------------------------------------------------
ANDA 85-934               Butabarbital Sodium Tablets, 30 mg      Do.
----------------------------------------------------------------------------------------------------------------
ANDA 85-938               Butabarbital Sodium Tablets, 15 mg      Do.
----------------------------------------------------------------------------------------------------------------
ANDA 86-171               Trichlormethiazide Tablets, 4 mg        Do.
----------------------------------------------------------------------------------------------------------------
ANDA 86-505               Hypaque-76 (diatrizoate meglumine and   GE Healthcare, Inc.
                           diatrizoate sodium injection USP)
----------------------------------------------------------------------------------------------------------------
ANDA 87-118               Chlorthalidone Tablets, 50 mg           Sadoz, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 87-282               Methocarbamol Tablets, 750 mg           Do.
----------------------------------------------------------------------------------------------------------------
ANDA 87-283               Methocarbamol Tablets, 500 mg           Do.
----------------------------------------------------------------------------------------------------------------
ANDA 87-449               Theophylline Oral Solution, 80 mg/15    Roxane Laboratories, Inc.
                           mL
----------------------------------------------------------------------------------------------------------------
ANDA 87-462               Theophylline Extended-Release           Sandoz, Inc.
                           Capsules, 260 mg
----------------------------------------------------------------------------------------------------------------
ANDA 88-157               Chlorpromazine HCl Intensol             Roxane Laboratories, Inc.
                           (chlorpromazine HCl oral concentrate
                           USP), 30 mg/mL
----------------------------------------------------------------------------------------------------------------
ANDA 88-158               Chlorpromazine HCl Intensol             Do.
                           (chlorpromazine HCl oral concentrate
                           USP), 100 mg/mL
----------------------------------------------------------------------------------------------------------------
ANDA 88-193               Triprolidine HCl and Pseudoephedrine    Sandoz, Inc.
                           HCl Tablets, 2.5 mg/60 mg
----------------------------------------------------------------------------------------------------------------
ANDA 88-587               Hydrochlorothiazide Oral Solution       Roxane Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 89-127               Mepro-Aspirin (aspirin and              Sandoz, Inc.
                           meprobamate) Tablets, 325 mg/200 mg
----------------------------------------------------------------------------------------------------------------
ANDA 89-508               Fluorouracil Injection USP, 50 mg/mL    Bedford Laboratories
----------------------------------------------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 355(e)) and under authority delegated 
to the Director, Center for Drug Evaluation and Research, by the 
Commissioner, approval of the applications listed in table 1 in this 
document, and all amendments and supplements thereto, is hereby 
withdrawn, effective August 20, 2010. Introduction or delivery for 
introduction into interstate commerce of products without approved new 
drug applications violates section 301(a) and (d) of the act (21 U.S.C. 
331(a) and (d)). Drug products that are listed in table 1 in this 
document that are in inventory on the date that this notice becomes 
effective (see the DATES section) may continue to be dispensed until 
the inventories have been depleted or the drug products have reached 
their expiration dates or otherwise become violative, whichever occurs 
first.

    Dated: June 15, 2010.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-17785 Filed 7-20-10; 8:45 am]
BILLING CODE 4160-01-S

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