[Federal Register Volume 60, Number 97 (Friday, May 19, 1995)]
[Notices]
[Page 26892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12295]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0127]
Roussel Corp., et al.; Withdrawal of Approval of 16 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 16 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withdrawn.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: June 19, 1995.
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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62-830................. Sterile Cefazolin Roussel Corp., 95
Sodium, U.S.P. (bulk). Chestnut Ridge Rd.,
P.O. Box 30,
Montvale, NJ 07645.
70-662................. Diazepam Injection, Fujisawa
U.S.P., 5 milligrams Pharmaceutical Co.,
(mg)/milliliter (mL). Parkway North Center,
Three Parkway North,
Deerfield, IL 60015-
2548.
80-517................. Prednisolone Sodium Steris Laboratories,
Phosphate Injection, Inc., 620 North 51st
U.S.P., 20 mg/mL. Ave., Phoenix, AZ
85043-4705.
80-702................. Vitamin A Palmitate Banner Pharmacaps,
Capsules, EQ 50,000 Inc., 1111 Jefferson
Units Base. Ave., Elizabeth, NJ
07207.
83-531................. Dimenhydrinate Steris Laboratories,
Injection, U.S.P., 50 Inc.
mg/mL.
83-593................. Chlorpheniramine Do.
Maleate Injection,
U.S.P., 10 mg/mL.
83-948................. Vitamin A Palmitate Banner Pharmacaps,
Capsules, EQ 50,000 Inc.
Units Base.
83-973................. Vitamin A Capsules, Do.
50,000 U.S.P. Units.
85-591................. Chlorpromazine Steris Laboratories,
Hydrochloride Inc.
Injection, U.S.P., 25
mg/mL.
86-419................. Testosterone Injection, Do.
U.S.P., 50 mg/mL.
86-420................. Testosterone Injection, Do.
U.S.P., 25 mg/mL.
86-468................. Procainamide Parke-Davis, Division
Hydrochloride Extended- of Warner-Lambert
release Tablets, Co., 2800 Plymouth
U.S.P., 250 mg. Rd., Ann Arbor, MI
48105.
86-844................. Acetic Acid Otic Procter & Gamble
Solution with Pharmaceuticals,
Hydrocortisone, 2%/1%. 11370 Reed Hartman
Hwy. Cincinnati, OH
45241-2422.
86-845................. Acetic Acid Otic Do.
Solution, U.S.P., 2%.
87-274................. Hydroxyzine Steris Laboratories,
Hydrochloride Inc.
Injection, U.S.P., 25
mg/mL and 50 mg/mL.
88-642................. Diethylpropion Lemmon Co., 650
Hydrochloride Tablets, Cathill Rd.,
U.S.P., 25 mg. Sellersville, PA
18960.
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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 June 19, 1995.
Dated: April 18, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-12295 Filed 5-18-95; 8:45 am]
BILLING CODE 4160-01-F
