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Schering Corp. et al.; Withdrawal of Approval of 51 New Drug Applications and 25 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 51 new drug applications (NDAs) and 25 abbreviated new drug applications (ANDAs). 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 September 17, 2001.

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

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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.DrugApplicant
NDA 3-158Oreton Methyl (methyltestosterone) Tablets, 10 milligrams (mg) and 25 mg.Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
NDA 5-963Sodium Sulamyd (sulfacetamide sodium) Ophthalmic Solution and Ointment.Do.
NDA 6-325Tubocurarine Chloride Injection.Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285.
NDA 6-632Metubine Iodide (metocurine iodide) Injection.Do.
NDA 6-772Vasoxyl (methoxamine hydrochloride (HCl)) Injection.GlaxoSmithKline (GSK), P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709.
NDA 6-925Nisentil (alphaprodine HCl) Injection.Hoffman-LaRoche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199.
NDA 7-600Surital (thiamylal sodium).Parkdale Pharmaceuticals, 2800 Plymouth Rd., Ann Arbor, MI 48105.
NDA 8-200Sodium Iodide I-131 Capsules, Solution, and Injection.Syncor International Corp., 6464 Canoga Ave., Woodland Hills, CA 91367.
NDA 8-592Ravocaine HCl (propoxycaine HCl and procaine HCl, with nordefrin or norepinephrine bitartrate).Eastman Kodak Co., Health Imaging, 343 State St., Rochester, NY 14612-1122.
NDA 9-127Cortril (hydrocortisone) Tablets.Pfizer, Inc., 235 East 42d St., New York, NY 10017.
NDA 9-130Cortril (hydrocortisone acetate) Ophthalmic Ointment.Do.
NDA 9-238Progesterone Injection.Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285.
NDA 9-458Cortisone Acetate Tablets, 25 mg.Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
NDA 9-996Sterane (prednisolone) Tablets.Pfizer, Inc.
NDA 10-423Lorfan (levallorphan tartrate) Injection.Hoffman-LaRoche, Inc.
NDA 10-554Magnacort (hydrocortamate HCl) Topical Ointment.Pfizer Pharmaceuticals, 235 East 42d St., New York, NY 10017.
NDA 11-539Ultra-Feminine (Topical Liquid).Coscelebre, Inc., 415 Madison Ave., New York, NY 10017.
NDA 11-557Trilafon (perphenazine) Concentrate, 16 mg/5 mL (milliliters).Schering Corp.
NDA 11-679Pentothal Sodium (thiopental sodium) Suspension.Abbott Laboratories, D-389, Bldg. AP30, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.
NDA 12-148Oreticyl Tablets and Oreticyle Forte (hydrochlorothiazide and deserpidine) Tablets.Do.
NDA 12-715Gantanol (sulfamethoxazole) Tablets.Hoffman-LaRoche, Inc.
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NDA 13-056Penthrane (methoxyflurane) Inhalation Liquid.Abbott Laboratories.
NDA 13-934Stoxil (idoxuridine) Ophthalmic Solution, 0.1%.SmithKline Beecham Pharmaceuticals, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101.
NDA 14-083Apodol (anileridine HCl) Tablets.Bristol-Myers Squibb, P.O. Box 4000, Princeton, NJ 08543-4000.
NDA 14-087Apodol (anileridine) Injection.Do.
NDA 15-868Stoxil (idoxuridine) Ophthalmic Ointment, 0.5%.SmithKline Beecham Pharmaceuticals.
NDA 17-255DTPA (chelate) Multidose (kit for the preparation of Tc-99m pentetate injection).Nycomed Amersham Imaging, 101 Carnegie Center, Princeton, NJ 08540.
NDA 17-256Xenon Xe-133.Do.
NDA 17-257Selenomethionine Se-75 Injection.Do.
NDA 17-266Technetium Tc-99m Sulfur Colloid Injection.Do.
NDA 17-267Sodium Pertechnetate Tc-99m Injection.Do.
NDA 17-383Methosarb (calusterone) Tablets.The Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001.
NDA 17-456Technetium Tc-99m Sulfur Colloid.Do.
NDA 17-483Methadone HCl Bulk (methadone HCl).Penick Corp., 158 Mount Olivet Ave., Newark, NJ 07114.
NDA 17-562Technetium Tc-99m Diphosphonate Injection (Tin Kit).Nycomed Amersham Imaging.
NDA 17-664Sodium Polyphosphate Injection (Tin Kit).Do.
NDA 17-667Stannous Diphosphonate Injection.Do.
NDA 18-228Hypnomidate (etomidate) Injection.Janssen Research Foundation, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560.
NDA 18-289Iodohippurate Sodium I-123.Nycomed Amersham Imaging.
NDA 18-871Protostat (metronidazole) Tablets.R. W. Johnson Pharmaceutical Research Institute, Route 202 South, P.O. Box 300, Raritan, NJ 08869-0602.
NDA 19-450Velosulin BR Human (semisynthetic purified human insulin) Injection.Novo Nordisk Pharmaceuticals, Inc., 100 College Rd. West, Princeton, NJ 08540.
NDA 20-420GenESA (arbutamine HCl) Injection.Gensia Automedics, Inc., 9360 Towne Centre Dr., San Diego, CA 92121.
NDA 20-689Posicor (miobefradil dihydrochloride) Oral Tablets, 50 mg and 100 mg.Hoffmann-LaRoche, Inc.
ANDA 40-059Fluocinolone Acetonide Topical Solution USP, 0.01%.Bausch & Lomb Pharmaceuticals, Inc., 8500 Hidden River Pkwy., Tampa, FL 33637.
NDA 50-311Rondomycin (methacycline HCl) Capsules.Pfizer, Inc.
NDA 50-448Grifulvin (griseofulvin) Oral Suspension.Johnson & Johnson Consumer Products Co., 199 Grandview Rd., Skillman, NJ 8558-9418.
NDA 50-637Zefazone (cefmetazole sodium) Sterile Powder.Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001.
NDA 50-683Zefazone (cefmetazole sodium) Intraveous Solution.Do.
ANDA 60-760Oxytetracycline HCl Capsules, 250 mg.Impax Laboratories, Inc.
ANDA 62-223Totacillin (Ampicillin Trihydrate for Oral Suspension USP).SmithKline Beecham Pharmaceuticals.
ANDA 62-736Bactocill (oxacillin sodium) Injection.GlaxoSmithKline (GSK).
ANDA 64-055Neomycin Sulfate and Dexamethosone Sodium Phosphate Ophthalmic SolutionBausch & Lomb Pharmaceuticals, Inc.
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ANDA 74-813Etoposide Injection 20 mg/mL.Pierre Fabre Medicament, c/o Guidelines Integrated Service, 10320 USA Today Way, Miramar, FL 33062.
ANDA 80-079Trisulfapyrimidines Tablets USP.Impax Laboratories, Inc.
ANDA 80-151Thyroglobulin Tablets USP.Do.
ANDA 80-153Isoniazid Tablets USP.Do.
ANDA 80-281Oreton Methyl Buccal Tablets (Methyltestosterone Tablets USP).Schering Corp.
ANDA 80-780Prednisolone Tablets USP, 5 mg.Impax Laboratories, Inc.
ANDA 80-807Diphenhydramine HCl Capsules USP, 25 mg and 50 mg.Do.
ANDA 80-951Ergocalciferol Capsules USP.Do.
ANDA 80-952Vitamin A Capsules USP.Do.
ANDA 80-953Vitamin A Capsules USP.Do.
ANDA 80-955Vitamin A Capsules USP.Do.
ANDA 83-011Hydrocortisone Cream USP, 1%.Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062.
ANDA 83-347Quinidine Sulfate Tablets USP, 200 mg.Impax Laboratories, Inc.
ANDA 84-214Promethazine HCl Tablets USP, 25 mg.Do.
ANDA 84-340Triamcinolone Tablets USP, 4 mg.Do.
ANDA 84-575Aminophylline Tablets USP, 200 mg.Do.
ANDA 84-577Aminophylline Tablets USP, 100 mg.Do.
ANDA 85-098Hydrocholorothiazide Tablets USP, 100 mg.Do.
ANDA 85-563Glycopyrrolate Tablets, 2 mg.Circa, 130 Lincoln St., Copiague, NY 11726.
ANDA 86-639Levsin PB (hyoscyamine sulfate and phenobarbital) Oral Solution.Schwarz Pharma, Inc., P.O. Box 2038, Milwaukee, WI 53201.

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 (21 CFR 5.82), approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective September 17, 2001.

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Dated: August 1, 2001.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

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[FR Doc. 01-20605 Filed 8-15-01; 8:45 am]