[Federal Register Volume 59, Number 62 (Thursday, March 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7633]
[[Page Unknown]]
[Federal Register: March 31, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0105]
Solvay Pharmaceuticals et al.; Withdrawal of Approval of 24
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 24 abbreviated new drug applications (ANDA's). The holders of the
ANDA's 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withdrawn.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: May 2, 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 ANDA's 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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ANDA no. Drug Applicant
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80-040 Sulfisoxazole Tablets, U.S.P., Solvay Pharmaceuticals, 901
500 milligrams (mg). Sawyer Rd., Marietta, GA
30062.
80-402 Folic Acid Tablets, 1 mg...... Do.
80-500 Rauwolfia Serpentina Tablets, Do.
U.S.P., 50 mg.
83-213 Hydrocortisone Acetate 0.5% Ferndale Laboratories, Inc.,
and Pramoxine Hydrochloride 780 West Eight Mile Rd.,
1% Lotion. Ferndale, MI 48220.
83-450 Sulfasalazine Tablets, U.S.P., Solvay Pharmaceuticals.
500 mg.
83-606 Butabarbital Sodium Tablets, Do.
U.S.P., 16.2 mg.
83-896 Butabarbital Sodium Tablets, Do.
U.S.P., 97.2 mg.
83-897 Butabarbital Sodium Tablets, Do.
U.S.P., 48.6 mg.
83-898 Butabarbital Sodium Tablets, Do.
U.S.P., 32.4 mg.
83-925 Hydrochlorothiazide Tablets, Do.
50 mg.
84-436 Dienestrol Vaginal Cream, Do.
0.01%.
84-448 Methocarbamol Tablets, U.S.P., Do.
500 mg.
84-449 Methocarbamol Tablets, U.S.P., Do.
750 mg.
84-777 Mepivacaine Hydrochloride Naska Pharmacal Co., Inc.,
Injection, U.S.P., 3%. Riverview Rd., P.O. Box 898,
Lincolnton, NC 28093.
85-010 Mepivacaine Hydrochloride and Do.
Levonordefrin Injection,
U.S.P..
85-323 Hydrochlorothiazide Tablets, Solvay Pharmaceuticals.
25 mg.
86-922 Isosorbide Dinitrate Par Pharmaceutical, Inc., One
Sublingual Tablets, U.S.P., 5 Ram Ridge Rd., Spring
mg. Valley, NY 10977.
86-924 Isosorbide Dinitrate Do.
Sublingual Tablets U.S.P.,
2.5 mg.
87-045 Aminophylline Oral Solution, Fisons Corp., Jefferson Rd.,
U.S.P.. P.O. Box 1710, Rochester, NY
14603.
87-144 Phentermine Hydrochloride Ferndale Laboratories, Inc.
Capsules, U.S.P., 30 mg.
87-609 Hydralazine Hydrochloride 100 Solvay Pharmaceuticals.
mg/Hydrochlorothiazide 50 mg
Capsules.
87-933 Isosorbide Dinitrate Par Pharmaceutical, Inc.
Sublingual Tablets, U.S.P..
88-041 Hydrocortisone Lotion, U.S.P., Solvay Pharmaceuticals.
1%.
88-860 Pseudoephedrine Hydrochloride Private Formulations, Inc.,
and Triprolidine 4600 Plainfield Ave.,
Hydrochloride Tablets, Edison, NJ 08818.
U.S.P., 2.5 mg/60 mg.
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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 ANDA's listed above, and all amendments and supplements
thereto, is hereby withdrawn, effective May 2, 1994.
Dated: March 14, 1994.
Roger L. Williams,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-7633 Filed 3-30-94; 8:45 am]
BILLING CODE 4160-01-F