[Federal Register Volume 66, Number 159 (Thursday, August 16, 2001)]
[Notices]
[Pages 43017-43019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20605]
[[Page 43017]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0336]
Schering Corp. et al.; Withdrawal of Approval of 51 New Drug
Applications and 25 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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requested that the approval of the applications be withdrawn.
DATES: Effective September 17, 2001.
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.
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Application No. Drug Applicant
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NDA 3-158 Oreton Methyl (methyltestosterone) Tablets, Schering Corp., 2000 Galloping Hill Rd.,
10 milligrams (mg) and 25 mg. Kenilworth, NJ 07033.
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NDA 5-963 Sodium Sulamyd (sulfacetamide sodium) Do.
Ophthalmic Solution and Ointment.
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NDA 6-325 Tubocurarine Chloride Injection. Lilly Research Laboratories, Lilly
Corporate Center, Indianapolis, IN 46285.
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NDA 6-632 Metubine Iodide (metocurine iodide) Do.
Injection.
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NDA 6-772 Vasoxyl (methoxamine hydrochloride (HCl)) GlaxoSmithKline (GSK), P.O. Box 13398,
Injection. Five Moore Dr., Research Triangle Park,
NC 27709.
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NDA 6-925 Nisentil (alphaprodine HCl) Injection. Hoffman-LaRoche, Inc., 340 Kingsland St.,
Nutley, NJ 07110-1199.
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NDA 7-600 Surital (thiamylal sodium). Parkdale Pharmaceuticals, 2800 Plymouth
Rd., Ann Arbor, MI 48105.
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NDA 8-200 Sodium Iodide I-131 Capsules, Solution, and Syncor International Corp., 6464 Canoga
Injection. Ave., Woodland Hills, CA 91367.
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NDA 8-592 Ravocaine HCl (propoxycaine HCl and Eastman Kodak Co., Health Imaging, 343
procaine HCl, with nordefrin or State St., Rochester, NY 14612-1122.
norepinephrine bitartrate).
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NDA 9-127 Cortril (hydrocortisone) Tablets. Pfizer, Inc., 235 East 42d St., New York,
NY 10017.
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NDA 9-130 Cortril (hydrocortisone acetate) Ophthalmic Do.
Ointment.
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NDA 9-238 Progesterone Injection. Eli Lilly and Co., Lilly Corporate Center,
Indianapolis, IN 46285.
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NDA 9-458 Cortisone Acetate Tablets, 25 mg. Impax Laboratories, Inc., 30831 Huntwood
Ave., Hayward, CA 94544.
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NDA 9-996 Sterane (prednisolone) Tablets. Pfizer, Inc.
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NDA 10-423 Lorfan (levallorphan tartrate) Injection. Hoffman-LaRoche, Inc.
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NDA 10-554 Magnacort (hydrocortamate HCl) Topical Pfizer Pharmaceuticals, 235 East 42d St.,
Ointment. New York, NY 10017.
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NDA 11-539 Ultra-Feminine (Topical Liquid). Coscelebre, Inc., 415 Madison Ave., New
York, NY 10017.
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NDA 11-557 Trilafon (perphenazine) Concentrate, 16 mg/ Schering Corp.
5 mL (milliliters).
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NDA 11-679 Pentothal Sodium (thiopental sodium) Abbott Laboratories, D-389, Bldg. AP30,
Suspension. 200 Abbott Park Rd., Abbott Park, IL
60064-6157.
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NDA 12-148 Oreticyl Tablets and Oreticyle Forte Do.
(hydrochlorothiazide and deserpidine)
Tablets.
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NDA 12-715 Gantanol (sulfamethoxazole) Tablets. Hoffman-LaRoche, Inc.
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[[Page 43018]]
NDA 13-056 Penthrane (methoxyflurane) Inhalation Abbott Laboratories.
Liquid.
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NDA 13-934 Stoxil (idoxuridine) Ophthalmic Solution, SmithKline Beecham Pharmaceuticals, One
0.1%. Franklin Plaza, P.O. Box 7929,
Philadelphia, PA 19101.
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NDA 14-083 Apodol (anileridine HCl) Tablets. Bristol-Myers Squibb, P.O. Box 4000,
Princeton, NJ 08543-4000.
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NDA 14-087 Apodol (anileridine) Injection. Do.
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NDA 15-868 Stoxil (idoxuridine) Ophthalmic Ointment, SmithKline Beecham Pharmaceuticals.
0.5%.
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NDA 17-255 DTPA (chelate) Multidose (kit for the Nycomed Amersham Imaging, 101 Carnegie
preparation of Tc-99m pentetate Center, Princeton, NJ 08540.
injection).
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NDA 17-256 Xenon Xe-133. Do.
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NDA 17-257 Selenomethionine Se-75 Injection. Do.
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NDA 17-266 Technetium Tc-99m Sulfur Colloid Injection. Do.
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NDA 17-267 Sodium Pertechnetate Tc-99m Injection. Do.
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NDA 17-383 Methosarb (calusterone) Tablets. The Upjohn Co., 7000 Portage Rd.,
Kalamazoo, MI 49001.
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NDA 17-456 Technetium Tc-99m Sulfur Colloid. Do.
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NDA 17-483 Methadone HCl Bulk (methadone HCl). Penick Corp., 158 Mount Olivet Ave.,
Newark, NJ 07114.
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NDA 17-562 Technetium Tc-99m Diphosphonate Injection Nycomed Amersham Imaging.
(Tin Kit).
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NDA 17-664 Sodium Polyphosphate Injection (Tin Kit). Do.
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NDA 17-667 Stannous Diphosphonate Injection. Do.
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NDA 18-228 Hypnomidate (etomidate) Injection. Janssen Research Foundation, 1125 Trenton-
Harbourton Rd., P.O. Box 200, Titusville,
NJ 08560.
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NDA 18-289 Iodohippurate Sodium I-123. Nycomed Amersham Imaging.
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NDA 18-871 Protostat (metronidazole) Tablets. R. W. Johnson Pharmaceutical Research
Institute, Route 202 South, P.O. Box 300,
Raritan, NJ 08869-0602.
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NDA 19-450 Velosulin BR Human (semisynthetic purified Novo Nordisk Pharmaceuticals, Inc., 100
human insulin) Injection. College Rd. West, Princeton, NJ 08540.
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NDA 20-420 GenESA (arbutamine HCl) Injection. Gensia Automedics, Inc., 9360 Towne Centre
Dr., San Diego, CA 92121.
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NDA 20-689 Posicor (miobefradil dihydrochloride) Oral Hoffmann-LaRoche, Inc.
Tablets, 50 mg and 100 mg.
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ANDA 40-059 Fluocinolone Acetonide Topical Solution Bausch & Lomb Pharmaceuticals, Inc., 8500
USP, 0.01%. Hidden River Pkwy., Tampa, FL 33637.
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NDA 50-311 Rondomycin (methacycline HCl) Capsules. Pfizer, Inc.
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NDA 50-448 Grifulvin (griseofulvin) Oral Suspension. Johnson & Johnson Consumer Products Co.,
199 Grandview Rd., Skillman, NJ 8558-
9418.
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NDA 50-637 Zefazone (cefmetazole sodium) Sterile Pharmacia & Upjohn Co., 7000 Portage Rd.,
Powder. Kalamazoo, MI 49001.
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NDA 50-683 Zefazone (cefmetazole sodium) Intraveous Do.
Solution.
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ANDA 60-760 Oxytetracycline HCl Capsules, 250 mg. Impax Laboratories, Inc.
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ANDA 62-223 Totacillin (Ampicillin Trihydrate for Oral SmithKline Beecham Pharmaceuticals.
Suspension USP).
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ANDA 62-736 Bactocill (oxacillin sodium) Injection. GlaxoSmithKline (GSK).
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ANDA 64-055 Neomycin Sulfate and Dexamethosone Sodium Bausch & Lomb Pharmaceuticals, Inc.
Phosphate Ophthalmic Solution
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[[Page 43019]]
ANDA 74-813 Etoposide Injection 20 mg/mL. Pierre Fabre Medicament, c/o Guidelines
Integrated Service, 10320 USA Today Way,
Miramar, FL 33062.
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ANDA 80-079 Trisulfapyrimidines Tablets USP. Impax Laboratories, Inc.
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ANDA 80-151 Thyroglobulin Tablets USP. Do.
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ANDA 80-153 Isoniazid Tablets USP. Do.
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ANDA 80-281 Oreton Methyl Buccal Tablets Schering Corp.
(Methyltestosterone Tablets USP).
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ANDA 80-780 Prednisolone Tablets USP, 5 mg. Impax Laboratories, Inc.
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ANDA 80-807 Diphenhydramine HCl Capsules USP, 25 mg and Do.
50 mg.
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ANDA 80-951 Ergocalciferol Capsules USP. Do.
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ANDA 80-952 Vitamin A Capsules USP. Do.
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ANDA 80-953 Vitamin A Capsules USP. Do.
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ANDA 80-955 Vitamin A Capsules USP. Do.
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ANDA 83-011 Hydrocortisone Cream USP, 1%. Solvay Pharmaceuticals, Inc., 901 Sawyer
Rd., Marietta, GA 30062.
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ANDA 83-347 Quinidine Sulfate Tablets USP, 200 mg. Impax Laboratories, Inc.
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ANDA 84-214 Promethazine HCl Tablets USP, 25 mg. Do.
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ANDA 84-340 Triamcinolone Tablets USP, 4 mg. Do.
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ANDA 84-575 Aminophylline Tablets USP, 200 mg. Do.
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ANDA 84-577 Aminophylline Tablets USP, 100 mg. Do.
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ANDA 85-098 Hydrocholorothiazide Tablets USP, 100 mg. Do.
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ANDA 85-563 Glycopyrrolate Tablets, 2 mg. Circa, 130 Lincoln St., Copiague, NY
11726.
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ANDA 86-639 Levsin PB (hyoscyamine sulfate and Schwarz Pharma, Inc., P.O. Box 2038,
phenobarbital) Oral Solution. Milwaukee, WI 53201.
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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.
Dated: August 1, 2001.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 01-20605 Filed 8-15-01; 8:45 am]
BILLING CODE 4160-01-S