[Federal Register Volume 60, Number 51 (Thursday, March 16, 1995)]
[Notices]
[Page 14289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6426]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0063]
Dey Laboratories, et al.; Withdrawal of Approval of 14
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 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withdrawn.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: April 17, 1995.
FOR FURTHER INFORMATION CONTACT: Carolyn C. Harris, 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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70-805................ Metaproterenol Sulfate Dey Laboratories, 2751
Inhalation Solution, Napa Valley Corporate
U.S.P., 5%. Dr., Napa, CA 94558.
80-086................ Sulfadiazine Tablets, Purepac
167 milligrams (mg) Pharmaceutical, Co.,
Sulfamerazine Tablets, 200 Elmora Ave.,
167 mg Sulfamethazine Elizabeth, NJ 07207.
Tablets, 167 mg.
80-120................ Isoniazid Tablets, 100 Towne, Paulsen & Co.,
mg. Inc., 14527 South San
Pedro St., Gardena,
CA 90248.
80-132................ Isoniazid Tablets, Purepac
U.S.P.. Pharmaceutical, Co.
80-276................ Testosterone Propionate Elkins-Sinn, Inc., 2
Injection. Esterbrook Lane,
Cherry Hill, NJ 08003-
4099.
80-308................ Methyltestosterone Purepac
Buccal Tablets, 10 mg. Pharmaceutical, Co.
80-309................ Methyltestosterone Do.
Tablets, 10 mg.
80-310................ Methyltestosterone Do.
Tablets, 25 mg.
80-459................ Hyrocortisone Emulsion Elder Pharmaceuticals,
Cream, 1%. Inc., ICN Plaza, 3300
Highland Ave., Costa
Mesa, CA 92626.
80-475................ Methyltestosterone Purepac
Tablets. Pharmaceuticals, Inc.
80-489................ Hydrocortisone Ointment, Altana Inc., 60 Baylis
0.5%. Rd., Melville, NY
11747.
80-581................ Pyridoxine Hydrochloride Elkins-Sinn, Inc.
Injection U.S.P., 100
mg/milliliter (mL).
80-797................ Chlorpheniramine Maleate Do.
Injection, 10 mg/mL and
100 mg/mL.
80-9 Propantheline Bromide Geneva
28. Tablets, 15 mg. Pharmaceuticals,
Inc., 2555 West
Midway Blvd.,
Broomfield, CO 80038-
0446.
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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 April 17, 1995.
Dated: March 2, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-6426 Filed 3-15-95; 8:45 am]
BILLING CODE 4160-01-F