[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requested that the approval of the applications be withdrawn.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.

[[Page 51360]]

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