Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications, 62858-62863 [E7-21886]

Download as PDF 62858 Federal Register / Vol. 72, No. 215 / Wednesday, November 7, 2007 / Notices Dated: October 29, 2007. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7–21842 Filed 11–6–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0427] Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. Application No. ACTION: Notice. The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing. SUPPLEMENTARY INFORMATION: SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 73 new drug applications (NDAs) and 62 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. EFFECTIVE DATE: December 7, 2007. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. Drug Applicant Hetrazan (diethylcarbamaxine citrate) Tablets and Syrup Lederle Laboratories, c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101–8299 NDA 6–799 Rubramin and Rubramin PC (cyanocobalamin injection USP) Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543–4000 NDA 7–517 Tapazole (methimazole tablets USP), 5 milligrams (mg) and 10 mg King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620 NDA 7–942 Sus-Phrine (epinephrine) Injection Forest Laboratories, Inc., Harborside Financial Center, Plaza Three, suite 602, Jersey City, NJ 07311 NDA 9–319 Ambenyl Expectorant and Ambenyl Cough Syrup Do. NDA l0–533 PBZ SR (tripelennamine HCl USP) Extended-Release Tablets Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936–1080 NDA 10–744 Darbid (isopropamide iodide) Tablets SmithKline Beecham Corp., d/b/a/ GlaxoSmith Kline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709 NDA 10–909 Miradon (anisindione) Tablets Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 NDA 11–213 Trilafon (perphenazine) Injection, 5 mg/milliliter (mL) Do. NDA 11–283 Kenacort (tramcinolone) Tablets Bristol-Myers Squibb Co. NDA 11–808 Mellaril (thioridazine HCl) Tablets Novartis Pharmaceuticals Corp. NDA 12–145 Prolixin (fluphenazine HCl) Elixir, 0.5 mg/mL Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543–4500 NDA 12–313 BIO-CLEAR (dibenzothiophene) Cream Helena Rubinstein, 202 Rodney Bldg., 3411 Silverside Rd., Wilmington, DE 19810 NDA 12–665 Velban (vinblastine sulfate) for Injection Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 NDA 12–678 pwalker on PROD1PC71 with NOTICES NDA 6–459 Tolbutamide Tablets Sandoz Inc., 227–15 North Conduit Ave., Laurelton, NY 11413 NDA 12–796 Quinidex Extentabs (quinidine sulfate extended-release tablets USP) Wyeth Pharmaceuticals, Inc. NDA 14–103 Oncovin (vincristine sulfate) Injection Eli Lilly and Co. NDA 14–242 Dexacort (dexamethasone sodium phosphate) Turbinaire UCB, 755 Jefferson Rd., Rochester, NY 14623 VerDate Aug<31>2005 16:14 Nov 06, 2007 Jkt 214001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1 Federal Register / Vol. 72, No. 215 / Wednesday, November 7, 2007 / Notices Application No. Drug 62859 Applicant Solbar (dioxybenzone and oxybenzone) Cream Person & Covey, Inc., 616 Allen Ave., Glendale, CA 91201 NDA 16–363 Lasix (furosemide) 10–mg/mL Injection Sanofi-Aventis, 300 Somerset Corporate Blvd., Bridgewater, NJ 08807–0977 NDA 16–408 WILDROOT (pyrithione zinc) Hair Groom and Grenadier Hair Groom Colgate-Palmolive Co., 909 River Rd., Piscataway, NJ 08854–5596 NDA 16–729 Ferrous Citrate Fe 59 Injection Mallinckrodt Inc., 675 McDowell Blvd., P.O. Box 5840, St. Louis, MO 63134 NDA 16–820 Emete-Con (benzquinamide HCl) Injection Pfizer, Inc., 235 East 42nd St., New York, NY 10017 NDA 16–847 Isopaque 440 (metrizoate sodium, meglumine metrizoate, calcium metrizoate, and metrizoate magnesium) Injection GE Healthcare, 101 Carnegie Center, Princeton, NJ 08540 NDA 17–430 Neggram (nalidixic acid USP) Suspension Sanofi-Aventis NDA 17–466 Bricanyl (terbutaline sulfate) Injection Sanofi-Aventis NDA 17–506 Isopaque 280 (metrizoic acid, meglumine, and calcium) Injection GE Healthcare NDA 17–613 Lotrimin (clotrimazole) Topical Solution, 1% Schering Corp. NDA 17–618 Bricanyl (terbutaline sulfate) Tablets Sanofi-Aventis NDA 17–619 Lotrimin (clotrimazole) Cream, 1% Schering Corp. NDA 17–668 Tenuate (diethylpropion HCl) Tablets, 25 mg Sanofi-Aventis NDA 17–669 Tenuate (diethylpropion HCl) Extended-Release Tablets, 75 mg Sanofi-Aventis NDA 17–688 Lasix (furosemide) Oral Solution, 10 mg/mL Sanofi-Aventis NDA 17–719 Dimeray (iocarmate meglumine) Injection Mallinckrodt Inc. NDA 17–725 Sodium Pertechnetate Tc–99m (technectium Tc–99m sodium pertechnetate) Mallinckrodt Inc. NDA 17–730 Isopaque 370 (metrizoic acid and meglume) Injection GE Healthcare NDA 17–769 Calcimar (calcitonin salmon) Injection Sanofi-Aventis NDA 17–838 Lungaggregate Reagent GE Healthcare NDA 17–848 Tc–99m Lungaggregate Do. NDA 17–907 Glucoscan Kit for the Preparation of Technetium Tc–99m Gluceptate Bristol-Myers Squibb Pharma Co., Chestnut Run Plaza, 974 Centre Rd., Wilmington, DE 19805 NDA 17–923 Mellaril-S (thioridazine HCl) Oral Suspension Novartis Pharmaceuticals Corp. NDA 17–956 Tepanil (diethylpropion HCl) Ten-Tabs 3M Pharmaceuticals, 3M Center, Bldg 0275–05–W–12, St. Paul, MN 55144–1000 NDA 18–000 Bricanyl (terbutaline sulfate) Inhaler Sanofi-Aventis NDA 18–067 Cinobac (cinoxacin) Capsules, 250 mg and 500 mg Eli Lilly and Co. NDA 18–088 Krypton Kr–81m Gas Generator GE Healthcare NDA 18–148 Nasalide (flunisolide) Nasal Spray IVAX Research, Inc., 4400 Biscayne Blvd., Miami, FL 33137 NDA 18–489 pwalker on PROD1PC71 with NOTICES NDA 14–262 Technescan HIDA (kit for the preparation of technetium Tc–99m lidofenin injection) Draximage, 16751 Autoroute TransCanada Highway, Kirkland, Quebec, H9H 4J4, Canada NDA 18–519 Irrigation Solution G (citric acid and sodium carbonate) Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR-AL, McGaw Park, IL 60085 NDA 18–554 Eulexin (flutamide) Capsules Schering Corp. VerDate Aug<31>2005 16:14 Nov 06, 2007 Jkt 214001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1 62860 Federal Register / Vol. 72, No. 215 / Wednesday, November 7, 2007 / Notices Application No. Drug Applicant Inocor (inamrinone lactate) Injection, 5 mg base/mL Sanofi-Synthelabo Inc., c/o Sanofi-Aventis, 300 Somerset Corporate Blvd., P.O. Box 6977, Bridgewater, NJ 08807–0977 NDA 18–770 Tornalate (bitolterol mesylate) Metered-Dose Inhaler Sanofi-Aventis NDA 18–813 Lotrimin (clotrimazole) Lotion, 1% Schering Corp. ANDA 18–862 Betatrex (betamethasone valerate cream USP, 0.1%) Savage Laboratories, 60 Baylis Rd., Melville, NY 11747 ANDA 18–863 Betatrex (betamethasone valerate ointment USP, 0.1%) Do. ANDA 18–867 Betatrex (betamethasone valerate lotion USP, 0.1%) Do. NDA 19–084 Nizoral (ketoconazole) Cream, 2% Johnson & Johnson Pharmaceutical Research & Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560 NDA 19–284 Oral Colonic Lavage (OCL) (sodium chloride, sodium bicarbonate, sodium sulfate, potassium chloride, and polyethelene glycol 3350) Hospira, Inc., 275 North Field Dr., Bldg. 2–J45–2, Lake Forest, Il 60045–5046 NDA 19–408 Diprolene (betamethasone dipropionate) Schering Corp. NDA 19–459 Photoplex (7% padimate O and 3% avobenzone) Lotion Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623–9534 NDA 19–520 Travasol (amino acid) in Dextrose Injection Baxter Healthcare Corp. NDA 19–545 Didronel (etidronate disodium) Injection MGI Pharma, Inc., 5775 West Old Shakopee Rd., suite 100, Bloomington, MN 55437–3174 NDA 19–548 Tornalate (bitolterol mesylate) Inhalatioon Solution, 0.2% Sanofi-Aventis NDA 19–576 Nizoral (ketoconazole) Cream, 2% Johnson & Johnson Pharmaceutical & Development, LLC NDA 19–648 Nizoral (ketoconazole) Cream, 2% Do. NDA 20–091 Imagent (perflubron) Alliance Pharmaceuticals Corp., 4660 La Jolla Dr., suite 740, San Diego, CA 92122 NDA 20–147 Travasol (amino acid) with Electrolytes in Dextrose Injection Baxter Healthcare Corp. NDA 20–228 Atrovent (ipratropium bromide) Inhalation Solution Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877–0368 NDA 20–303 Prempro/Premphase (conjugated estrogens and medroxyprogesterone acetate) Tablets Wyeth Pharmaceuticals, Inc. NDA 20–315 Orlaam (levomethadyl acetate HCl) Oral Solution Roxane Laboratories, P.O. Box 16532, Columbus, OH 43216–6532 NDA 20–486 Vanceril (beclomethasone dipropionate) Double Strength Aerosol Schering Corp. NDA 20–887 AcuTect Kit for the Preparation of Technetium Tc–99m Apticide Injection CIS-US, Inc., 10 De Angelo Dr., Bedford, MA 01730 NDA 21–012 Neo-Tect Kit for the Preparation of Technetium Tc–99m Depreotide Injection Do. NDA 21–075 Nutropin Depot (somatropin recombinant) Genentech Inc., 1 DNA Way MSι242, South San Francisco, CA 94080–4990 ANDA 40–098 pwalker on PROD1PC71 with NOTICES NDA 18–700 Acetaminophen and Codeine Phosphate Oral Solution USP Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512 NDA 50–477 Nebcin (tobramycin sulfate) for Injection Eli Lilly and Co. NDA 50–519 Nebcin (tobramycin sulfate) for Injection Do. VerDate Aug<31>2005 16:14 Nov 06, 2007 Jkt 214001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1 Federal Register / Vol. 72, No. 215 / Wednesday, November 7, 2007 / Notices Application No. Drug 62861 Applicant Dynabac (dirithromycin delayed-release tablets USP) Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 ANDA 60–212 Grisactin (griseofulvin microcrystalline) Tablets, 500 mg Wyeth Ayerst Laboratories, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101 ANDA 60–570 Fungizone (amphotericin B lotion USP), 3% Apothecon, c/o Bristol-Myers Squibb Co. ANDA 60–751 NEO-CORTEF (neomycin sulfate and hydrocortisone acetate) Ointment Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017 ANDA 61–007 Terramycin (oxytetracycline HCl, polymyxin B sulfate) Topical Ointment with Polymyxin B Sulfate Pfizer, Inc. ANDA 61–131 Nystatin Powder USP Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. ANDA 61–411 Veetids (penicillin V potassium tablets USP), 250 mg and 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 61–737 ZIBA-Rx (bacitracin zinc USP) X-GEN Pharmaceuticals, Inc., P.O. Box 1148, Elmira, NY 14902 ANDA 61–859 Anspor (cephradine) Capsules, 250 mg and 500 mg GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101–7929 ANDA 61–866 Anspor (cephradine) for Oral Suspension Do. ANDA 61–876 Cerubidine Injection (daunorubice HCl for injection USP) Sanofi-Aventis ANDA 62–519 Nystex (nystatin) Oral Suspension USP, 100,000 units/mL Savage Laboratories ANDA 62–560 Mandol (cefamadole nafate for injection USP) Eli Lilly and Co. ANDA 62–739 Tazidime (ceftazidime) Do. ANDA 62–745 Cephalexin Tablets USP Do. ANDA 62–888 Principen (ampicillin capsules USP), 250 mg and 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 62–926 Rubex (doxorubicin HCl for injection USP) Bristol-Myers Squibb Co. ANDA 63–021 Kanamycin Sulfate Injection USP, 75 mg/2 mL Loch Pharmaceuticals, c/o Bedford Laboratories, A Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146 ANDA 63–022 Kanamycin Sulfate Injection USP, 500 mg/2 mL Do. ANDA 63–025 Kanamycin Sulfate Injection USP, 1 gram (g)/3 mL Do. ANDA 63–099 Trimox (amoxicillin capsules USP), 250 mg and 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 70–867 Vincrex (vincristine sulfate for injection USP), 5 mg/vial Bristol-Myers Squibb Co. ANDA 71–742 Clorazepate Dipotassium Capsules, 3.75 mg Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. ANDA 71–743 Clorazepate Dipotassium Capsules, 7.5 mg Do. ANDA 71–744 Clorazepate Dipotassium Capsules, 15 mg Do. ANDA 72–326 Fenoprofen Calcium Tablets USP, 600 mg Do. ANDA 72–507 Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mg Do. ANDA 72–508 pwalker on PROD1PC71 with NOTICES NDA 50–678 Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mg Do. ANDA 72–509 Methyldopa and Hydrochlorothiazide Tables USP, 500 mg/30 mg Do. ANDA 72–510 Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mg Do. VerDate Aug<31>2005 16:14 Nov 06, 2007 Jkt 214001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1 62862 Federal Register / Vol. 72, No. 215 / Wednesday, November 7, 2007 / Notices Application No. Drug Applicant Prazosin HCl Capsules USP, 1 mg Do. ANDA 72–706 Prazosin HCl Capsules USP, 2 mg Do. ANDA 72–707 Prazosin HCL Capsules USP, 5 mg Do. ANDA 74–258 Metoprolol Tartrate Tablets USP, 50 mg and 100 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 74–423 Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg Clonmel Healthcare, Ltd., c/o of STADA Pharmaceuticals Inc. ANDA 74–472 Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 75–407 Morphine Sulfate Extended-Release Tablets USP, 15 mg Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. ANDA 80–745 Aristocort (triamcinolone acetonide) Ointment, 0.5% Astellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015–2537 ANDA 80–750 Aristocort (triamcinolone acetonide) Ointment, 0.1% Do. ANDA 83–015 Aristocort (triamcinolone acetonide) Cream, 0.5% Do. ANDA 83–016 Aristocort (triamcinolone acetonide) Cream, 0.1% Do. ANDA 83–017 Aristocort (triamcinolone acetonide) Cream, 0.025% Do. ANDA 83–149 PBZ (tripelennamine HCl) Tablet, 25 mg Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936–1080 ANDA 83–317 Propoxyphene HCl Capsules, 65 mg Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 ANDA 83–380 Aristogel (triamcinolone acetonide) Gel, 0.1% Astellas Pharma US, Inc. ANDA 83–881 Aristocort A (triamcinolone acetonide) Spray Do. ANDA 86–212 Chlordiazepoxide HCl Capsules, 25 mg Impax Laboratories, Inc. ANDA 86–213 Chlordiazepoxide Capsules, 5 mg Do. ANDA 86–358 Mexate (methotrexate sodium for injection) Bristol-Myers Squibb Co. ANDA 86–926 Tolbutamide Tablets USP, 500 mg Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. ANDA 87–011 Quinidine Sulfate Tablets USP, 200 mg Do. ANDA 87–677 Hydrocodone Bitartrate and Acetaminophen B.F. Ascher & Co., Inc., 15501 West 109th St., Lenexa, KS 66219 ANDA 87–887 TRYSUL (triple sulfa vaginal cream USP) Savage Laboratories ANDA 88–584 DHC Plus (dihydrocodeine bitartrate, acetaminophen, and caffeine) Capsules The Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901–3431 ANDA 88–760 Mexate-AQ (methotrexate sodium injection USP), 25 mg Bristol-Myers Squibb Co. ANDA 88–780 Aristocort A Ointment (triamcinolone acetonide ointment USP), 0.1% Astellas Pharma US, Inc. ANDA 88–781 Aristocort A (triamcinolone acetonide) Ointment, 0.5% Do. ANDA 88–944 Sedapap (butalbital and acetaminophen) Tablets, 50 mg/ 650 mg Merz Pharmaceuticals, LLC, 4215 Tudor Lane, Greensboro, NC 27410 ANDA 89–887 pwalker on PROD1PC71 with NOTICES ANDA 72–705 Mexate-AQ Preserved (methotrexate sodium injection USP), 25 mg/mL Bristol-Myers Squibb Co. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and under authority VerDate Aug<31>2005 16:14 Nov 06, 2007 Jkt 214001 delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 applications listed in the table in this document, and all amendments and E:\FR\FM\07NON1.SGM 07NON1 Federal Register / Vol. 72, No. 215 / Wednesday, November 7, 2007 / Notices supplements thereto, is hereby withdrawn, effective December 7, 2007. Dated: October 26, 2007. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E7–21886 Filed 11–6–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [CIS No. 2427–07; DHS Docket No. USCIS– 2007–0054] RIN No. 1615–ZA62 Announcement of a Stakeholder Meeting on the Evaluation of E-Verify U.S. Citizenship and Immigration Services, DHS. ACTION: Notice of meeting. AGENCY: SUMMARY: The E-Verify program, formerly Basic Pilot, is an online tool that allows participating employers to confirm the employment eligibility of their newly hired employees, regardless of citizenship, to help maintain a stable, legal workforce. The purpose of this Notice is to announce to interested members of the public a stakeholder meeting on the evaluation of the EVerify Program to identify program strengths and weaknesses from multiple perspectives and to assist the evaluation staff in prioritizing research topics. Date and Time: The meeting will be held on Tuesday, November 27, 2007, from 8:30 a.m. to 5 p.m. ADDRESSES: The meeting will be held at the Washington Court Hotel, 525 New Jersey Avenue, NW., Washington, DC 20001. FOR FURTHER INFORMATION CONTACT: Sara Speckhard, U.S. Citizenship and Immigration Services (USCIS), Department of Homeland Security, Office of Policy & Strategy, 20 Massachusetts Avenue, NW., Room 4012, Washington, DC 20529. Telephone: (202) 272–1470. Research contact: Ms. Marsha Lyons, Westat, 1650 Research Boulevard, Rockville, MD 20850. Telephone: (301) 517–4050, Fax: (301) 294–3992. E-mail: MarshaLyons@westat.com. On September 15, 1997, the legacy Immigration and Naturalization Service (INS) published a notice in the Federal Register describing pilot programs that were required by section 403 of the Illegal Immigration Reform and pwalker on PROD1PC71 with NOTICES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 16:14 Nov 06, 2007 Jkt 214001 Immigrant Responsibility Act of 1996 (IIRIRA). On December 20, 2004, the U.S. Citizenship and Immigration Services (USCIS) announced the extension of one of these programs, the Basic Pilot, to November 30, 2008. Renamed E-Verify, the current program constitutes an online modification of the Basic Pilot and allows participating employers to confirm the employment eligibility of their newly hired employees regardless of citizenship to help maintain a stable, legal workforce. E-Verify is operated jointly by USCIS and the Social Security Administration. An evaluation of the current E-Verify program is being conducted by Westat, Inc. This notice announces a public meeting to seek stakeholder input regarding the E-Verify program. Summary of Agenda • Introductions and Purpose. • Update on E-Verify. • Overview of the Key Findings of the FY2007 evaluation and the current evaluation goals. • Break-out group discussions to address topics such as using biometrics for verification, resolving tentative confirmations, timing of employee verifications, and focusing on specific types of employers (i.e., designated agents, employers using designated agents, employment agencies and temporary help agencies, inactive employers). • Reports from break-out groups. • Questions and comments. Public Participation The meeting is open to the public, but advance notice of attendance is requested to ensure adequate seating. In the event that requests for attendance exceed available space, it may not be possible to honor all requests. Persons planning to attend should notify Ms. Lyons at least 5 days prior to the meeting. Dated: November 1, 2007. Jonathan R. Scharfen, Deputy Director, U.S. Citizenship and Immigration Services. [FR Doc. E7–21829 Filed 11–6–07; 8:45 am] BILLING CODE 4410–10–P DEPARTMENT OF THE INTERIOR Bureau of Land Management [WO–260–09–1060–00–24 1A] Notice of Extension for the Call for Nominations for the Wild Horse and Burro Advisory Board AGENCY: Bureau of Land Management, Interior. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 ACTION: 62863 Notice of Extension. SUMMARY: The purpose of this notice is to extend the submission date to solicit nominations for the Wild Horse and Burro Advisory Board. The Federal Register notice for nominations published in the Federal Register on September 17, 2007 [72 FR 52906]. DATES: This notice extends the date to December 7, 2007. ADDRESSES: The nominations should be submitted to the National Wild Horse and Burro Program, Bureau of Land Management, Department of Interior, P.O. Box 12000, Reno, Nevada 89520– 0006, Attn: Ramona DeLorme: fax (775) 861-6711. FOR FURTHER INFORMATION CONTACT: Don Glenn, Acting Division Chief, Wild Horse and Burro Group, (202) 452–5082. Individuals who use a telecommunications device for the deaf (TDD) may reach Ms. DeLorme at any time by calling the Federal Information Relay Service at 1 (800) 877–8339. Dated: October 30, 2007. Bud Cribley, Deputy Assistant Director, Renewable Resources and Planning. [FR Doc. E7–21887 Filed 11–6–07; 8:45 am] BILLING CODE 4310–84–P INTERNATIONAL TRADE COMMISSION [Investigation No. 337–TA–613] In the Matter of Certain 3G Mobile Handsets and Components Thereof; Notice of Commission Decision Not To Review an Initial Determination Granting Complainants’ Motion To Amend the Complaint and Notice of Investigation U.S. International Trade Commission. ACTION: Notice. AGENCY: SUMMARY: Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (‘‘ID’’) (Order No. 3) issued by the presiding administrative law judge (‘‘ALJ’’) granting complainants’ motion to amend the complaint and notice of investigation. FOR FURTHER INFORMATION CONTACT: Michelle Walters, Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 708–5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 72, Number 215 (Wednesday, November 7, 2007)]
[Notices]
[Pages 62858-62863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21886]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0427]


Lederle Laboratories et al.; Withdrawal of Approval of 73 New 
Drug Applications and 62 Abbreviated New Drug Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of 73 new drug applications (NDAs) and 62 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.
EFFECTIVE DATE: December 7, 2007.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
the table in this document have informed FDA that these drug products 
are no longer marketed and have requested that FDA withdraw approval of 
the applications. The applicants have also, by their requests, waived 
their opportunity for a hearing.

------------------------------------------------------------------------
 Application No.              Drug                     Applicant
------------------------------------------------------------------------
NDA 6-459          Hetrazan                    Lederle Laboratories, c/o
                    (diethylcarbamaxine         Wyeth Pharmaceuticals,
                    citrate) Tablets and        Inc., P.O. Box 8299,
                    Syrup                       Philadelphia, PA 19101-
                                                8299
------------------------------------------------------------------------
NDA 6-799          Rubramin and Rubramin PC    Bristol-Myers Squibb Co.,
                    (cyanocobalamin injection   P.O. Box 4000,
                    USP)                        Princeton, NJ 08543-4000
------------------------------------------------------------------------
NDA 7-517          Tapazole (methimazole       King Pharmaceuticals,
                    tablets USP), 5             Inc., 501 Fifth St.,
                    milligrams (mg) and 10 mg   Bristol, TN 37620
------------------------------------------------------------------------
NDA 7-942          Sus-Phrine (epinephrine)    Forest Laboratories,
                    Injection                   Inc., Harborside
                                                Financial Center, Plaza
                                                Three, suite 602, Jersey
                                                City, NJ 07311
------------------------------------------------------------------------
NDA 9-319          Ambenyl Expectorant and     Do.
                    Ambenyl Cough Syrup
------------------------------------------------------------------------
NDA l0-533         PBZ SR (tripelennamine HCl  Novartis Pharmaceuticals
                    USP) Extended-Release       Corp., One Health Plaza,
                    Tablets                     East Hanover, NJ 07936-
                                                1080
------------------------------------------------------------------------
NDA 10-744         Darbid (isopropamide        SmithKline Beecham Corp.,
                    iodide) Tablets             d/b/a/ GlaxoSmith Kline,
                                                P.O. Box 13398, Five
                                                Moore Dr., Research
                                                Triangle Park, NC 27709
------------------------------------------------------------------------
NDA 10-909         Miradon (anisindione)       Schering Corp., 2000
                    Tablets                     Galloping Hill Rd.,
                                                Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 11-213         Trilafon (perphenazine)     Do.
                    Injection, 5 mg/
                    milliliter (mL)
------------------------------------------------------------------------
NDA 11-283         Kenacort (tramcinolone)     Bristol-Myers Squibb Co.
                    Tablets
------------------------------------------------------------------------
NDA 11-808         Mellaril (thioridazine      Novartis Pharmaceuticals
                    HCl) Tablets                Corp.
------------------------------------------------------------------------
NDA 12-145         Prolixin (fluphenazine      Apothecon, c/o Bristol-
                    HCl) Elixir, 0.5 mg/mL      Myers Squibb Co., P.O.
                                                Box 4500, Princeton, NJ
                                                08543-4500
------------------------------------------------------------------------
NDA 12-313         BIO-CLEAR                   Helena Rubinstein, 202
                    (dibenzothiophene) Cream    Rodney Bldg., 3411
                                                Silverside Rd.,
                                                Wilmington, DE 19810
------------------------------------------------------------------------
NDA 12-665         Velban (vinblastine         Eli Lilly and Co., Lilly
                    sulfate) for Injection      Corporate Center,
                                                Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 12-678         Tolbutamide Tablets         Sandoz Inc., 227-15 North
                                                Conduit Ave., Laurelton,
                                                NY 11413
------------------------------------------------------------------------
NDA 12-796         Quinidex Extentabs          Wyeth Pharmaceuticals,
                    (quinidine sulfate          Inc.
                    extended-release tablets
                    USP)
------------------------------------------------------------------------
NDA 14-103         Oncovin (vincristine        Eli Lilly and Co.
                    sulfate) Injection
------------------------------------------------------------------------
NDA 14-242         Dexacort (dexamethasone     UCB, 755 Jefferson Rd.,
                    sodium phosphate)           Rochester, NY 14623
                    Turbinaire
------------------------------------------------------------------------

[[Page 62859]]

 
NDA 14-262         Solbar (dioxybenzone and    Person & Covey, Inc., 616
                    oxybenzone) Cream           Allen Ave., Glendale, CA
                                                91201
------------------------------------------------------------------------
NDA 16-363         Lasix (furosemide) 10-mg/   Sanofi-Aventis, 300
                    mL Injection                Somerset Corporate
                                                Blvd., Bridgewater, NJ
                                                08807-0977
------------------------------------------------------------------------
NDA 16-408         WILDROOT (pyrithione zinc)  Colgate-Palmolive Co.,
                    Hair Groom and Grenadier    909 River Rd.,
                    Hair Groom                  Piscataway, NJ 08854-
                                                5596
------------------------------------------------------------------------
NDA 16-729         Ferrous Citrate Fe 59       Mallinckrodt Inc., 675
                    Injection                   McDowell Blvd., P.O. Box
                                                5840, St. Louis, MO
                                                63134
------------------------------------------------------------------------
NDA 16-820         Emete-Con (benzquinamide    Pfizer, Inc., 235 East
                    HCl) Injection              42nd St., New York, NY
                                                10017
------------------------------------------------------------------------
NDA 16-847         Isopaque 440 (metrizoate    GE Healthcare, 101
                    sodium, meglumine           Carnegie Center,
                    metrizoate, calcium         Princeton, NJ 08540
                    metrizoate, and
                    metrizoate magnesium)
                    Injection
------------------------------------------------------------------------
NDA 17-430         Neggram (nalidixic acid     Sanofi-Aventis
                    USP) Suspension
------------------------------------------------------------------------
NDA 17-466         Bricanyl (terbutaline       Sanofi-Aventis
                    sulfate) Injection
------------------------------------------------------------------------
NDA 17-506         Isopaque 280 (metrizoic     GE Healthcare
                    acid, meglumine, and
                    calcium) Injection
------------------------------------------------------------------------
NDA 17-613         Lotrimin (clotrimazole)     Schering Corp.
                    Topical Solution, 1%
------------------------------------------------------------------------
NDA 17-618         Bricanyl (terbutaline       Sanofi-Aventis
                    sulfate) Tablets
------------------------------------------------------------------------
NDA 17-619         Lotrimin (clotrimazole)     Schering Corp.
                    Cream, 1%
------------------------------------------------------------------------
NDA 17-668         Tenuate (diethylpropion     Sanofi-Aventis
                    HCl) Tablets, 25 mg
------------------------------------------------------------------------
NDA 17-669         Tenuate (diethylpropion     Sanofi-Aventis
                    HCl) Extended-Release
                    Tablets, 75 mg
------------------------------------------------------------------------
NDA 17-688         Lasix (furosemide) Oral     Sanofi-Aventis
                    Solution, 10 mg/mL
------------------------------------------------------------------------
NDA 17-719         Dimeray (iocarmate          Mallinckrodt Inc.
                    meglumine) Injection
------------------------------------------------------------------------
NDA 17-725         Sodium Pertechnetate Tc-    Mallinckrodt Inc.
                    99m (technectium Tc-99m
                    sodium pertechnetate)
------------------------------------------------------------------------
NDA 17-730         Isopaque 370 (metrizoic     GE Healthcare
                    acid and meglume)
                    Injection
------------------------------------------------------------------------
NDA 17-769         Calcimar (calcitonin        Sanofi-Aventis
                    salmon) Injection
------------------------------------------------------------------------
NDA 17-838         Lungaggregate Reagent       GE Healthcare
------------------------------------------------------------------------
NDA 17-848         Tc-99m Lungaggregate        Do.
------------------------------------------------------------------------
NDA 17-907         Glucoscan Kit for the       Bristol-Myers Squibb
                    Preparation of Technetium   Pharma Co., Chestnut Run
                    Tc-99m Gluceptate           Plaza, 974 Centre Rd.,
                                                Wilmington, DE 19805
------------------------------------------------------------------------
NDA 17-923         Mellaril-S (thioridazine    Novartis Pharmaceuticals
                    HCl) Oral Suspension        Corp.
------------------------------------------------------------------------
NDA 17-956         Tepanil (diethylpropion     3M Pharmaceuticals, 3M
                    HCl) Ten-Tabs               Center, Bldg 0275-05-W-
                                                12, St. Paul, MN 55144-
                                                1000
------------------------------------------------------------------------
NDA 18-000         Bricanyl (terbutaline       Sanofi-Aventis
                    sulfate) Inhaler
------------------------------------------------------------------------
NDA 18-067         Cinobac (cinoxacin)         Eli Lilly and Co.
                    Capsules, 250 mg and 500
                    mg
------------------------------------------------------------------------
NDA 18-088         Krypton Kr-81m Gas          GE Healthcare
                    Generator
------------------------------------------------------------------------
NDA 18-148         Nasalide (flunisolide)      IVAX Research, Inc., 4400
                    Nasal Spray                 Biscayne Blvd., Miami,
                                                FL 33137
------------------------------------------------------------------------
NDA 18-489         Technescan HIDA (kit for    Draximage, 16751
                    the preparation of          Autoroute TransCanada
                    technetium Tc-99m           Highway, Kirkland,
                    lidofenin injection)        Quebec, H9H 4J4, Canada
------------------------------------------------------------------------
NDA 18-519         Irrigation Solution G       Baxter Healthcare Corp.,
                    (citric acid and sodium     1620 Waukegan Rd., MPGR-
                    carbonate)                  AL, McGaw Park, IL 60085
------------------------------------------------------------------------
NDA 18-554         Eulexin (flutamide)         Schering Corp.
                    Capsules
------------------------------------------------------------------------

[[Page 62860]]

 
NDA 18-700         Inocor (inamrinone          Sanofi-Synthelabo Inc., c/
                    lactate) Injection, 5 mg    o Sanofi-Aventis, 300
                    base/mL                     Somerset Corporate
                                                Blvd., P.O. Box 6977,
                                                Bridgewater, NJ 08807-
                                                0977
------------------------------------------------------------------------
NDA 18-770         Tornalate (bitolterol       Sanofi-Aventis
                    mesylate) Metered-Dose
                    Inhaler
------------------------------------------------------------------------
NDA 18-813         Lotrimin (clotrimazole)     Schering Corp.
                    Lotion, 1%
------------------------------------------------------------------------
ANDA 18-862        Betatrex (betamethasone     Savage Laboratories, 60
                    valerate cream USP, 0.1%)   Baylis Rd., Melville, NY
                                                11747
------------------------------------------------------------------------
ANDA 18-863        Betatrex (betamethasone     Do.
                    valerate ointment USP,
                    0.1%)
------------------------------------------------------------------------
ANDA 18-867        Betatrex (betamethasone     Do.
                    valerate lotion USP,
                    0.1%)
------------------------------------------------------------------------
NDA 19-084         Nizoral (ketoconazole)      Johnson & Johnson
                    Cream, 2%                   Pharmaceutical Research
                                                & Development, LLC, c/o
                                                Janssen Pharmaceutical
                                                Products, LP, 1125
                                                Trenton-Harbourton Rd.,
                                                P.O. Box 200,
                                                Titusville, NJ 08560
------------------------------------------------------------------------
NDA 19-284         Oral Colonic Lavage (OCL)   Hospira, Inc., 275 North
                    (sodium chloride, sodium    Field Dr., Bldg. 2-J45-
                    bicarbonate, sodium         2, Lake Forest, Il 60045-
                    sulfate, potassium          5046
                    chloride, and
                    polyethelene glycol 3350)
------------------------------------------------------------------------
NDA 19-408         Diprolene (betamethasone    Schering Corp.
                    dipropionate)
------------------------------------------------------------------------
NDA 19-459         Photoplex (7% padimate O    Allergan, 2525 Dupont
                    and 3% avobenzone) Lotion   Dr., P.O. Box 19534,
                                                Irvine, CA 92623-9534
------------------------------------------------------------------------
NDA 19-520         Travasol (amino acid) in    Baxter Healthcare Corp.
                    Dextrose Injection
------------------------------------------------------------------------
NDA 19-545         Didronel (etidronate        MGI Pharma, Inc., 5775
                    disodium) Injection         West Old Shakopee Rd.,
                                                suite 100, Bloomington,
                                                MN 55437-3174
------------------------------------------------------------------------
NDA 19-548         Tornalate (bitolterol       Sanofi-Aventis
                    mesylate) Inhalatioon
                    Solution, 0.2%
------------------------------------------------------------------------
NDA 19-576         Nizoral (ketoconazole)      Johnson & Johnson
                    Cream, 2%                   Pharmaceutical &
                                                Development, LLC
------------------------------------------------------------------------
NDA 19-648         Nizoral (ketoconazole)      Do.
                    Cream, 2%
------------------------------------------------------------------------
NDA 20-091         Imagent (perflubron)        Alliance Pharmaceuticals
                                                Corp., 4660 La Jolla
                                                Dr., suite 740, San
                                                Diego, CA 92122
------------------------------------------------------------------------
NDA 20-147         Travasol (amino acid) with  Baxter Healthcare Corp.
                    Electrolytes in Dextrose
                    Injection
------------------------------------------------------------------------
NDA 20-228         Atrovent (ipratropium       Boehringer Ingelheim
                    bromide) Inhalation         Pharmaceuticals, Inc.,
                    Solution                    900 Ridgebury Rd., P.O.
                                                Box 368, Ridgefield, CT
                                                06877-0368
------------------------------------------------------------------------
NDA 20-303         Prempro/Premphase           Wyeth Pharmaceuticals,
                    (conjugated estrogens and   Inc.
                    medroxyprogesterone
                    acetate) Tablets
------------------------------------------------------------------------
NDA 20-315         Orlaam (levomethadyl        Roxane Laboratories, P.O.
                    acetate HCl) Oral           Box 16532, Columbus, OH
                    Solution                    43216-6532
------------------------------------------------------------------------
NDA 20-486         Vanceril (beclomethasone    Schering Corp.
                    dipropionate) Double
                    Strength Aerosol
------------------------------------------------------------------------
NDA 20-887         AcuTect Kit for the         CIS-US, Inc., 10 De
                    Preparation of Technetium   Angelo Dr., Bedford, MA
                    Tc-99m Apticide Injection   01730
------------------------------------------------------------------------
NDA 21-012         Neo-Tect Kit for the        Do.
                    Preparation of Technetium
                    Tc-99m Depreotide
                    Injection
------------------------------------------------------------------------
NDA 21-075         Nutropin Depot (somatropin  Genentech Inc., 1 DNA Way
                    recombinant)                MS242, South
                                                San Francisco, CA 94080-
                                                4990
------------------------------------------------------------------------
ANDA 40-098        Acetaminophen and Codeine   Clonmel Healthcare, Ltd.,
                    Phosphate Oral Solution     c/o STADA
                    USP                         Pharmaceuticals Inc.,
                                                U.S. Agent, 5 Cedar
                                                Brook Dr., Cranbury, NJ
                                                08512
------------------------------------------------------------------------
NDA 50-477         Nebcin (tobramycin          Eli Lilly and Co.
                    sulfate) for Injection
------------------------------------------------------------------------
NDA 50-519         Nebcin (tobramycin          Do.
                    sulfate) for Injection
------------------------------------------------------------------------

[[Page 62861]]

 
NDA 50-678         Dynabac (dirithromycin      Lilly Research
                    delayed-release tablets     Laboratories, Lilly
                    USP)                        Corporate Center,
                                                Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 60-212        Grisactin (griseofulvin     Wyeth Ayerst
                    microcrystalline)           Laboratories, c/o Wyeth
                    Tablets, 500 mg             Pharmaceuticals, P.O.
                                                Box 8299, Philadelphia,
                                                PA 19101
------------------------------------------------------------------------
ANDA 60-570        Fungizone (amphotericin B   Apothecon, c/o Bristol-
                    lotion USP), 3%             Myers Squibb Co.
------------------------------------------------------------------------
ANDA 60-751        NEO-CORTEF (neomycin        Pharmacia & Upjohn Co., c/
                    sulfate and                 o Pfizer, Inc., 235 East
                    hydrocortisone acetate)     42nd St., New York, NY
                    Ointment                    10017
------------------------------------------------------------------------
ANDA 61-007        Terramycin                  Pfizer, Inc.
                    (oxytetracycline HCl,
                    polymyxin B sulfate)
                    Topical Ointment with
                    Polymyxin B Sulfate
------------------------------------------------------------------------
ANDA 61-131        Nystatin Powder USP         Clonmel Healthcare, Ltd.,
                                                c/o STADA
                                                Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 61-411        Veetids (penicillin V       Apothecon, c/o Bristol-
                    potassium tablets USP),     Myers Squibb Co.
                    250 mg and 500 mg
------------------------------------------------------------------------
ANDA 61-737        ZIBA-Rx (bacitracin zinc    X-GEN Pharmaceuticals,
                    USP)                        Inc., P.O. Box 1148,
                                                Elmira, NY 14902
------------------------------------------------------------------------
ANDA 61-859        Anspor (cephradine)         GlaxoSmithKline, One
                    Capsules, 250 mg and 500    Franklin Plaza, P.O. Box
                    mg                          7929, Philadelphia, PA
                                                19101-7929
------------------------------------------------------------------------
ANDA 61-866        Anspor (cephradine) for     Do.
                    Oral Suspension
------------------------------------------------------------------------
ANDA 61-876        Cerubidine Injection        Sanofi-Aventis
                    (daunorubice HCl for
                    injection USP)
------------------------------------------------------------------------
ANDA 62-519        Nystex (nystatin) Oral      Savage Laboratories
                    Suspension USP, 100,000
                    units/mL
------------------------------------------------------------------------
ANDA 62-560        Mandol (cefamadole nafate   Eli Lilly and Co.
                    for injection USP)
------------------------------------------------------------------------
ANDA 62-739        Tazidime (ceftazidime)      Do.
------------------------------------------------------------------------
ANDA 62-745        Cephalexin Tablets USP      Do.
------------------------------------------------------------------------
ANDA 62-888        Principen (ampicillin       Apothecon, c/o Bristol-
                    capsules USP), 250 mg and   Myers Squibb Co.
                    500 mg
------------------------------------------------------------------------
ANDA 62-926        Rubex (doxorubicin HCl for  Bristol-Myers Squibb Co.
                    injection USP)
------------------------------------------------------------------------
ANDA 63-021        Kanamycin Sulfate           Loch Pharmaceuticals, c/o
                    Injection USP, 75 mg/2 mL   Bedford Laboratories, A
                                                Division of Ben Venue
                                                Laboratories, Inc., 300
                                                Northfield Rd., Bedford,
                                                OH 44146
------------------------------------------------------------------------
ANDA 63-022        Kanamycin Sulfate           Do.
                    Injection USP, 500 mg/2
                    mL
------------------------------------------------------------------------
ANDA 63-025        Kanamycin Sulfate           Do.
                    Injection USP, 1 gram (g)/
                    3 mL
------------------------------------------------------------------------
ANDA 63-099        Trimox (amoxicillin         Apothecon, c/o Bristol-
                    capsules USP), 250 mg and   Myers Squibb Co.
                    500 mg
------------------------------------------------------------------------
ANDA 70-867        Vincrex (vincristine        Bristol-Myers Squibb Co.
                    sulfate for injection
                    USP), 5 mg/vial
------------------------------------------------------------------------
ANDA 71-742        Clorazepate Dipotassium     Clonmel Healthcare, Ltd.,
                    Capsules, 3.75 mg           c/o STADA
                                                Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 71-743        Clorazepate Dipotassium     Do.
                    Capsules, 7.5 mg
------------------------------------------------------------------------
ANDA 71-744        Clorazepate Dipotassium     Do.
                    Capsules, 15 mg
------------------------------------------------------------------------
ANDA 72-326        Fenoprofen Calcium Tablets  Do.
                    USP, 600 mg
------------------------------------------------------------------------
ANDA 72-507        Methyldopa and              Do.
                    Hydrochlorothiazide
                    Tablets USP, 250 mg/15 mg
------------------------------------------------------------------------
ANDA 72-508        Methyldopa and              Do.
                    Hydrochlorothiazide
                    Tablets USP, 250 mg/25 mg
------------------------------------------------------------------------
ANDA 72-509        Methyldopa and              Do.
                    Hydrochlorothiazide
                    Tables USP, 500 mg/30 mg
------------------------------------------------------------------------
ANDA 72-510        Methyldopa and              Do.
                    Hydrochlorothiazide
                    Tablets USP, 500 mg/50 mg
------------------------------------------------------------------------

[[Page 62862]]

 
ANDA 72-705        Prazosin HCl Capsules USP,  Do.
                    1 mg
------------------------------------------------------------------------
ANDA 72-706        Prazosin HCl Capsules USP,  Do.
                    2 mg
------------------------------------------------------------------------
ANDA 72-707        Prazosin HCL Capsules USP,  Do.
                    5 mg
------------------------------------------------------------------------
ANDA 74-258        Metoprolol Tartrate         Apothecon, c/o Bristol-
                    Tablets USP, 50 mg and      Myers Squibb Co.
                    100 mg
------------------------------------------------------------------------
ANDA 74-423        Captopril Tablets USP,      Clonmel Healthcare, Ltd.,
                    12.5 mg, 25 mg, 50 mg,      c/o of STADA
                    and 100 mg                  Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 74-472        Captopril Tablets USP,      Apothecon, c/o Bristol-
                    12.5 mg, 25 mg, 50 mg,      Myers Squibb Co.
                    and 100 mg
------------------------------------------------------------------------
ANDA 75-407        Morphine Sulfate Extended-  Clonmel Healthcare, Ltd.,
                    Release Tablets USP, 15     c/o STADA
                    mg                          Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 80-745        Aristocort (triamcinolone   Astellas Pharma US, Inc.,
                    acetonide) Ointment, 0.5%   Three Parkway North,
                                                Deerfield, IL 60015-2537
------------------------------------------------------------------------
ANDA 80-750        Aristocort (triamcinolone   Do.
                    acetonide) Ointment, 0.1%
------------------------------------------------------------------------
ANDA 83-015        Aristocort (triamcinolone   Do.
                    acetonide) Cream, 0.5%
------------------------------------------------------------------------
ANDA 83-016        Aristocort (triamcinolone   Do.
                    acetonide) Cream, 0.1%
------------------------------------------------------------------------
ANDA 83-017        Aristocort (triamcinolone   Do.
                    acetonide) Cream, 0.025%
------------------------------------------------------------------------
ANDA 83-149        PBZ (tripelennamine HCl)    Novartis Pharmaceuticals
                    Tablet, 25 mg               Corp., 59 Route 10, East
                                                Hanover, NJ 07936-1080
------------------------------------------------------------------------
ANDA 83-317        Propoxyphene HCl Capsules,  Impax Laboratories, Inc.,
                    65 mg                       30831 Huntwood Ave.,
                                                Hayward, CA 94544
------------------------------------------------------------------------
ANDA 83-380        Aristogel (triamcinolone    Astellas Pharma US, Inc.
                    acetonide) Gel, 0.1%
------------------------------------------------------------------------
ANDA 83-881        Aristocort A                Do.
                    (triamcinolone acetonide)
                    Spray
------------------------------------------------------------------------
ANDA 86-212        Chlordiazepoxide HCl        Impax Laboratories, Inc.
                    Capsules, 25 mg
------------------------------------------------------------------------
ANDA 86-213        Chlordiazepoxide Capsules,  Do.
                    5 mg
------------------------------------------------------------------------
ANDA 86-358        Mexate (methotrexate        Bristol-Myers Squibb Co.
                    sodium for injection)
------------------------------------------------------------------------
ANDA 86-926        Tolbutamide Tablets USP,    Clonmel Healthcare, Ltd.,
                    500 mg                      c/o STADA
                                                Pharmaceuticals Inc.
------------------------------------------------------------------------
ANDA 87-011        Quinidine Sulfate Tablets   Do.
                    USP, 200 mg
------------------------------------------------------------------------
ANDA 87-677        Hydrocodone Bitartrate and  B.F. Ascher & Co., Inc.,
                    Acetaminophen               15501 West 109th St.,
                                                Lenexa, KS 66219
------------------------------------------------------------------------
ANDA 87-887        TRYSUL (triple sulfa        Savage Laboratories
                    vaginal cream USP)
------------------------------------------------------------------------
ANDA 88-584        DHC Plus (dihydrocodeine    The Purdue Frederick Co.,
                    bitartrate,                 One Stamford Forum,
                    acetaminophen, and          Stamford, CT 06901-3431
                    caffeine) Capsules
------------------------------------------------------------------------
ANDA 88-760        Mexate-AQ (methotrexate     Bristol-Myers Squibb Co.
                    sodium injection USP), 25
                    mg
------------------------------------------------------------------------
ANDA 88-780        Aristocort A Ointment       Astellas Pharma US, Inc.
                    (triamcinolone acetonide
                    ointment USP), 0.1%
------------------------------------------------------------------------
ANDA 88-781        Aristocort A                Do.
                    (triamcinolone acetonide)
                    Ointment, 0.5%
------------------------------------------------------------------------
ANDA 88-944        Sedapap (butalbital and     Merz Pharmaceuticals,
                    acetaminophen) Tablets,     LLC, 4215 Tudor Lane,
                    50 mg/650 mg                Greensboro, NC 27410
------------------------------------------------------------------------
ANDA 89-887        Mexate-AQ Preserved         Bristol-Myers Squibb Co.
                    (methotrexate sodium
                    injection USP), 25 mg/mL
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic 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 the table in this document, and 
all amendments and

[[Page 62863]]

supplements thereto, is hereby withdrawn, effective December 7, 2007.

    Dated: October 26, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-21886 Filed 11-6-07; 8:45 am]
BILLING CODE 4160-01-S
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