[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Notices]
[Pages 63347-63349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31214]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0479]
Parke-Davis et al.; Withdrawal of Approval of 18 New Drug
Applications, 7 Abbreviated Antibiotic Applications, and 53 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 18 new drug applications (NDA's), 7 abbreviated antibiotic
applications (AADA's), and 53 abbreviated new drug applications
(ANDA's). 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that the approval of the applications be withdrawn.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 29, 1997.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, 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 request, waived
their opportunity for a hearing.
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Application No. Drug Applicant
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NDA 6-413.......................... Super Anahist (neohetramine Parke-Davis, 2800 Plymouth Rd., Ann
hydrochloride). Arbor, MI 48105.
NDA 7-812.......................... Inhiston-APC (aspirin 3.5 grains Plough, Inc., P.O. Box 377, Memphis,
(gr), caffeine 0.5 gr, phenacetin TN 38151.
2.5 gr, pheniramine maleate 10
milligrams (mg).
NDA 9-108.......................... Rauval (rauwolfia serpentina) Tablets Glenwood-Palisades, P.O. Box 369,
One New England Ave., Piscataway,
NY 08855.
NDA 11-760......................... Normacol (polycarbophil) Tablets..... Schering Corp., 2000 Galloping Hill
Rd., Kenilworth, NY 07033.
NDA 11-935......................... Actifed (pseudoephedrine Glaxo Wellcome Inc., Five Moore Dr.,
hydrochloride and triprolidine Research Triangle Park, NC 27709.
hydrochloride) Syrup.
NDA 11-936......................... Actifed (pseudoephedrine Do.
hydrochloride and triprolidine
hydrochloride) Tablets.
NDA 11-950......................... Tacaryl (methdilazine hydrochloride) Westwood-Squibb Pharmaceuticals,
Syrup, 4 mg/15 milliliters (mL). Inc., 100 Forest Ave., Buffalo, NY
14213-1091.
NDA 12-939......................... Neutrapen (penicillinase injectable). 3M Pharmaceuticals, Bldg. 260-6A-22,
3M Center, St. Paul, MN 55144-1000.
NDA 15-438......................... Meprobamate Tablets USP, 200 mg, 400 Zenith Goldline Pharmaceuticals, 140
mg. Legrand Ave., Northvale, NJ 07647.
NDA 16-649......................... Feminone Tablets..................... Pharmacia & Upjohn, 7000 Portage
Rd., Kalamazoo, MI 49001-0199.
NDA 17-369......................... Teldrin (chlorpheniramine maleate SmithKline Beecham Consumer
extended release) Spansules. Healthcare, 1500 Littleton Rd.,
Parsippany, NY 07054-3884.
NDA 17-906......................... Lactulose Syrup...................... Solvay Pharmaceuticals, Inc., 901
Sawyer Rd., Marietta, GA 30062.
NDA 19-014......................... Benylin Decongestant Cough Formula Warner-Lambert Co., 170 Tabor Rd.,
(diphenhydramine hydrocholoride and Morris Plains, NJ 07950.
pseudoephedrine hydrochloride).
NDA 50-125......................... Tablets Remanden-250 (Potassium Merck & Co., Inc., BLA-30, West
Penicillin G with Probenecid). Point, PA 19486.
NDA 50-137......................... Cer-O-Cillin Sodium (crystalline Pharmacia & Upjohn
sodium penicillin O).
[[Page 63348]]
NDA 50-298......................... Pyopen (sterile carbenicillin SmithKline Beecham Pharmaceuticals,
disodium) Injection. P.O. Box 7929, Philadelphia, PA
19101-7929.
NDA 50-375......................... Cremomycin Oral Suspension........... Merck & Co., Inc.
NDA 50-566......................... Sterile Cefazolin Sodium Injection in Baxter Healthcare Corp., Rt. 120 and
PL146 Plastic Container. Wilson Rd., Round Lake, IL 60073-
0490.
AADA 60-571........................ MYCOSTATIN (Nystatin) Ointment Westwood-Squibb Pharmaceuticals,
100,000 USP units per gram (g). Inc.
AADA 60-634........................ Oxytetracycline Hydrochloride Purepac Pharmaceutical Co., 200
Capsules USP, 250 mg. Elmora Ave., Elizabeth, NJ 07207.
AADA 62-471........................ Gentamicin Sulfate Cream, USP 0.1%... Alpharma, U.S. Pharmaceuticals Div.,
Johns Hopkins Bayview Center, 333
Cassell Dr., suite 3500, Baltimore,
MD 21224.
AADA 62-496........................ Gentamicin Sulfate Ointment, USP 0.1% Do.
AADA 62-583........................ Bacitracin (sterile)................. Alpharma AS, U.S. Agent: Alpharma
Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024.
AADA 62-584........................ Bacitracin Zinc (nonsterile)......... Do.
AADA 63-250........................ Amoxicillin Trihydrate, nonsterile Ranbaxy Laboratories Ltd., U.S.
bulk. Agent: Ranbaxy Pharmaceuticals,
Inc., 4600 Marriott Dr., suite 100,
Raleigh, NC 27612.
ANDA 70-136........................ Propranolol Hydrochloride Injection SoloPak Laboratories, 1845 Tonne
USP, 1 mg/mL (syringe). Rd., Elk Grove Village, IL 60007-
5125.
ANDA 70-579........................ Allopurinol Tablets USP, 100 mg...... Purepac Pharmaceutical Co.
ANDA 70-688........................ Methyldopa and Hydrochlorothiazide Do.
Tablets USP, 250 mg/25 mg.
ANDA 70-695........................ Verapamil Hydrochloride Injection SoloPak Laboratories
USP, 2.5 mg/mL (syringe).
ANDA 70-800........................ Haloperidol Injection USP, 5 mg/mL Do.
(syringe).
ANDA 70-853........................ Methyldopa and Hydrochlorothiazide Purepac Pharmaceutical Co.
Tablets USP, 250 mg/15 mg.
ANDA 70-854........................ Methyldopa and Hydrochlorothiazide Do.
Tablets USP, 250 mg/30 mg.
ANDA 71-000........................ Amantadine Hydrochloride Capsules Solvay Pharmaceuticals, Inc.
USP, 100 mg.
ANDA 71-123........................ Ibuprofen Tablets USP, 300 mg........ Purepac Pharmaceutical Co.
ANDA 71-124........................ Ibuprofen Tablets USP, 400 mg........ Do.
ANDA 71-125........................ Ibuprofen Tablets USP, 600 mg........ Do.
ANDA 71-672........................ Naloxone Hydrochloride Injection USP, SoloPak Laboratories
0.02 mg/mL (syringe).
ANDA 71-683........................ Naloxone Hydrochloride Injection USP, Do.
0.4 mg/mL (syringe).
ANDA 72-110........................ Doxepin Hydrochloride Capsules USP, Purepac Pharmaceutical Co.
100 mg.
ANDA 72-330........................ Clorazepate Dipotassium Tablets, 3.75 Do.
mg.
ANDA 72-331........................ Clorazepate Dipotassium Tablets, 7.5 Do.
mg.
ANDA 72-332........................ Clorazepate Dipotassium Tablets, 15 Do.
mg.
ANDA 72-386........................ Doxepin Hydrochloride Capsules USP, Do.
75 mg.
ANDA 72-387........................ Doxepin Hydrochloride Capsules USP, Do.
150 mg.
ANDA 80-493........................ Cortisone Acetate Tablets USP, 25 mg. Do.
ANDA 80-842........................ Rauwolfia Serpentina Tablets USP, 50 Do.
mg and 100 mg.
ANDA 80-845........................ Diphenhydramine Hydrochloride Eon Labs Manufacturing, Inc., 227-15
Capsules USP, 25 mg and 50 mg. North Conduit Ave., Laurelton, NY
11413.
ANDA 84-138........................ Phendimetrazine Tartrate Tablets, 35 KV Pharmaceutical Co., 2503 South
mg (Pink). Hanley Rd., St. Louis, MO 63144-
2555.
ANDA 84-141........................ Phendimetrazine Tartrate Tablets, 35 Do.
mg.
ANDA 84-479........................ Dicyclomine Hydrochloride Syrup USP, Alpharma, U.S. Pharmaceuticals Div.
10 mg/5 mL.
ANDA 84-932........................ Quinidine Sulfate USP, 200 mg Solvay Pharmaceuticals, Inc.
(Tablets).
ANDA 85-296........................ Quinidine Sulfate USP, 200 mg Do.
(Capsules).
ANDA 85-297........................ Quinidine Sulfate USP, 300 mg Do.
(Capsules).
ANDA 85-298........................ Quinidine Sulfate USP, 300 mg Do.
(Tablets).
ANDA 85-299........................ Quinidine Sulfate USP, 100 mg Do.
(Tablets).
ANDA 86-298........................ UNIPRES (Reserpine, Hydralazine Do.
Hydrochloride, and
Hydrochlorothiazide Tablets, USP)
0.1 mg/25 mg/15 mg.
ANDA 86-822........................ Hydroxyzine Hydrochloride Injection SoloPak Laboratories
USP, 25 mg/mL (syringe).
ANDA 87-043........................ Heparin Sodium Injection USP, 1,000 Do.
units/mL (syringe).
ANDA 87-077........................ Heparin Sodium Injection USP, 5,000 Do.
units/mL (syringe).
ANDA 87-101........................ Isoetharine Inhalation Solution, USP Alpharma, U.S. Pharmaceuticals Div.
1%.
[[Page 63349]]
ANDA 87-107........................ Heparin Sodium Injection USP, 10,000 SoloPak Laboratories
units/mL (syringe).
ANDA 87-109........................ Nitroglycerin Extended-Release KV Pharmaceutical Co.
Capsules, 9 mg.
ANDA 87-310........................ Hydroxyzine Hydrochloride Injection SoloPak Laboratories
USP, 50 mg/mL.
ANDA 87-344........................ Isosorbide Dinitrate Extended-release Inwood Laboratories, Inc., 909 Third
Capsules, 40 mg. Ave., New York, NY 10022-4731.
ANDA 87-363........................ Heparin Sodium Injection USP, 10,000 SoloPak Laboratories
units/0.5 mL (syringe).
ANDA 87-395........................ Heparin Sodium Injection USP, 5,000 Do.
units/0.5 mL (syringe).
ANDA 87-551........................ Cyanocobalamin Injection USP, 1,000 Do.
micrograms/mL (syringe).
ANDA 87-596........................ Hydroxyzine Hydrochloride Injection Do.
USP, 50 mg/mL and 100 mg/mL.
ANDA 87-903........................ Heparin Lock Flush Solution USP, 10 Do.
units/mL (syringe).
ANDA 87-905........................ Heparin Lock Flush Solution USP, 100 Do.
units/mL (syringe).
ANDA 88-120........................ Hydroxyzine Hydrochloride Tablets Purepac Pharmaceutical Co.
USP, 10 mg.
ANDA 88-121........................ Hydroxyzine Hydrochloride Tablets Do.
USP, 25 mg.
ANDA 88-122........................ Hydroxyzine Hydrochloride Tablets Do.
USP, 50 mg.
ANDA 88-139........................ Chlorthalidone Tablets USP, 25 mg.... Do.
ANDA 88-177........................ Hydralazine Hydrochloride Tablets, 25 Do.
mg.
ANDA 88-520........................ Phenytoin Sodium Injection USP, 50 mg/ SoloPak Laboratories
mL (syringe).
ANDA 88-532........................ Procainamide Hydrochloride Injection Do.
USP, 500 mg/mL (syringe).
ANDA 89-094........................ Trimethobenzamide Hydrochloride Do.
Injection USP, 100 mg/mL (syringe).
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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
December 29, 1997.
Dated: November 17, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-31214 Filed 11-26-97; 8:45 am]
BILLING CODE 4160-01-F