[Federal Register Volume 59, Number 132 (Tuesday, July 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16735]
[[Page Unknown]]
[Federal Register: July 12, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0249]
Sandoz Pharmaceuticals Corp., et al.; Withdrawal of Approval of 7
Abbreviated Antibiotic Applications and 11 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 7 abbreviated antibiotic applications (AADA's) and 11 abbreviated
new drug applications (ANDA's). The holders of these 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withdrawn.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: August 11, 1994.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug
Evaluation and Research (HFD-360), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1038.
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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AADA, 62-025........ Griseofulvin, U.S.P. Sandoz Pharmaceuticals
(Nonsterile bulk). Corp., 59 Rt. 10, East
Hanover, NJ 07936-1080.
AADA, 62-323........ Amoxicillin Oral Apothecon, Inc., P.O.
Suspension, U.S.P., 125 Box 4500, Princeton, NJ
milligrams (mg)/5 08543-4500.
milliliters (mL) and
250 mg/5 mL.
AADA, 62-541........ Nystatin Oral Pharmafair, Inc., 110
Suspension, U.S.P., Kennedy Dr., Hauppauge,
100,000 units/mL. NY 11788.
AADA, 62-616........ Erythromycin Topical Do.
Solution, U.S.P., 2%.
AADA, 62-694........ Ampicillin Trihydrate, Sandoz Pharmaceuticals
U.S.P. (Nonsterile Corp.
bulk).
AADA, 62-728........ Amphotericin B for Fujisawa USA, Inc.,
Injection, U.S.P., 50 Parkway North Center,
mg/vial. Three Parkway North,
Deerfield, IL 60015-
2548.
AADA, 63-219........ Amoxicillin Trihydrate, Sandoz Pharmaceuticals
U.S.P. (Nonsterile Corp.
bulk).
ANDA, 71-038........ Lorazepam Tablets, Warner Chilcott
U.S.P., 1 mg. Laboratories, 201 Tabor
Rd., Morris Plains, NJ
07950.
ANDA, 71-039........ Lorazepam Tablets, Do.
U.S.P., 2 mg.
ANDA, 80-431........ Metaraminol Bitartrate Fujisawa USA, Inc.
Injection, U.S.P., 10
mg/mL.
ANDA, 80-446........ Reserpine Tablets, Solvay Pharmaceuticals,
U.S.P., 0.25 mg. Inc., 901 Sawyer Rd.,
Marietta, GA 30062.
ANDA, 80-563........ Prednisone Tablets, MK Labs, 11 Fairway
U.S.P., 2.5 mg and 5 mg. Lane, Trumbull, CT
06611.
ANDA, 84-035........ Phentermine Solvay Pharmaceuticals,
Hydrochloride Tablets, Inc.
U.S.P., 8 mg.
ANDA, 86-867........ Prednisone Tablets, Danbury Pharmacal, Inc.,
U.S.P., 50 mg. 131 West St., Danbury,
CT 06810.
ANDA, 87-556........ Reserpine, Hydralazine Do.
Hydrochloride, and
Hydrochlorothiazide
Tablets, U.S.P., 0.1 mg/
25 mg/15 mg.
ANDA, 87-674........ Phenylbutazone Tablets, Do.
U.S.P., 100 mg.
ANDA, 88-087........ Proparacaine Pharmafair, Inc.
Hydrochloride
Ophthalmic Solution,
U.S.P., 0.5%.
ANDA, 89-572........ Pyridostigmine Bromide Solvay Pharmaceuticals,
Tablets, U.S.P., 30 mg. 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 above, and all amendments and
supplements thereto, is hereby withdrawn, effective August 11, 1994.
Dated: June 25, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 94-16735 Filed 7-11-94; 8:45 am]
BILLING CODE 4160-01-P