[Federal Register Volume 63, Number 186 (Friday, September 25, 1998)]
[Notices]
[Pages 51359-51360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25713]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0787]
Parke-Davis Pharmaceutical Research et al.; Withdrawal of
Approval of 14 New Drug Applications and 13 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 14 new drug applications (NDA's) and 13 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requested that the approval of the applications be withdrawn.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: September 25, 1998.
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 3-402 Pitressin Tannate in Oil (Vasopressin Tannate), 5 Pressor Parke-Davis Pharmaceutical Research, 2800 Plymouth Rd., Ann
Units, 1 milliliter Arbor, MI 48105.
NDA 6-212 Propylthiouracil Tablets Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL
60064.
NDA 10-355 Quarzan (clindium bromide) Capsules Hoffmann-LaRoche Inc., 340 Kingsland St., Nutley, NJ 07110-
1199.
NDA 12-184 Norlutate (Norethindrone Acetate) 5-milligram (mg) Tablets Parke-Davis Pharmaceuticals, 2800 Plymouth Rd., Ann Arbor, MI
48105.
NDA 12-470 Akrinol Cream Schering-Plough Corp., 2000 Galloping Hill Rd., Kenilworth, NJ
07033.
NDA 13-294 Azo-Gantanol (sulfa-methoxazole and phenazo-pyridine Hoffmann-La Roche Inc.
hydrochloride) Tablets
NDA 16-020 Symmetrel (amantadine hydro-chloride) Capsules, 100 mg Endo Pharmaceuticals, Inc., 500 Endo Blvd., Garden City, NY
11530.
NDA 16-191 Sorbitrate (isosorbide dinitrate) Sublingual Tablets, 2.5 and Zeneca Pharmaceuticals, a business unit of Zeneca, Inc., 1800
5 mg Concord Pike, P.O. Box 15437, Wilmington, DE 19850-5437.
NDA 17-117 Symmetrel (amantadine hydro-chloride) Capsules Endo Pharmaceuticals, Inc.
NDA 17-552 Tylenol Acetminophen Extra Strength Tablets, 500 mg McNeil Consumer Products Co., 7050 Camp Hill Rd., Fort
Washington, PA 19034-2299.
NDA 18-179 Valrelease (diazepam) Capsules Hoffman-LaRoche Inc.
NDA 50-345 Cordran N Ointment (flurandrenolide) Lilly Research Laboratories.
NDA 50-346 Cordran N Cream (flurandrenolide) Do.
NDA 50-379 Sterile Ophthalmic Solution Neo-Hydeltrasol (neomycin sulfate- Merck & Co., Inc., P.O. Box 4, BLA-20, West Point, PA 19486.
prednisolone sodium phosphate ophthalmic solution)
ANDA 62-385 Neomycin Sulfate Powder, USP (for compounding oral products) Paddock Laboratories, Inc., 3940 Quebec Ave. North,
Minneapolis, MN 55427.
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ANDA 62-455 Polymyxin B Sulfate, USP (for prescription compounding) Do.
ANDA 62-456 Bacitracin Powder, USP (for prescription compounding) Do.
ANDA 74-084 Diltiazem Hydrochloride Tablets USP, 30 mg and 60 mg Novopharm N.C., Inc., agent for Novopharm Ltd., 4700 Novopharm
Blvd., Wilson, NC 27893.
ANDA 74-511 SULSTER (Sulfacetamide Sodium and Prednisolone Sodium Taylor Pharmaceuticals (an Akorn Co.), 150 South Wyckles Rd.,
Phosphate Ophthalmic Solution, 10%/eq. 0.23% phosphate) P.O. Box 1220, Decatur, IL 62525-1220.
ANDA 80-025 Sulf-10 (Sulfacetamide Sodium Ophthalmic Solution, USP) 10% Ciba Vision, 11460 Johns Creek Pkwy., Duluth, GA 30097-1556.
ANDA 83-648 Meprotabs (Meprobamate Tablets USP, 400 mg) Wallace Laboratories, Division of Carter-Wallace, Inc., Half
Acre Rd., P.O. Box 1001, Cranberry, NJ 08512-0181.
ANDA 85-136 Methocarbamol Tablets USP (750 mg) Forest Laboratories, Inc., 909 Third Ave., New York, NY 10022-
4731.
ANDA 85-137 Methocarbamaol Tablets USP (500 mg) Inwood Laboratories, Inc., 909 Third Ave., New York, NY 10022-
4731.
ANDA 86-228 Nitroglycerin Extended-release Capsules (2.5 mg) Geneva Pharmaceuticals, Inc., 2655 West Midway Blvd., P.O. Box
446, Broomfield, CO 80038-0446.
ANDA 86-230 Nitroglycerin Extended-release Capsules (6.5 mg) Do.
ANDA 87-797 Triamcinolone Acetonide Cream USP, 0.025% Alpharma USPD, Inc., 333 Cassell Dr., suite 3500, Baltimore,
MD 21224.
ANDA 88-220 Nitroglycerin Extended-release Capsules (9 mg) Geneva Pharmaceuticals, Inc.
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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 25, 1998.
Dated: September 14, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-25713 Filed 9-24-98; 8:45 am]
BILLING CODE 4160-01-F