[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Notices]
[Pages 11106-11107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5060]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0051]
Solvay Pharmaceuticals, Inc., et al.; Withdrawal of Approval of
11 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 11 abbreviated antibiotic applications (AADA's) and 11 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withdrawn.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: March 31, 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 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.
[[Page 11107]]
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AADA No. Drug Applicant
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60-128.................. Ampicillin Trihydrate. IBI, Giovanni
Lorenzini S.p.A.,
20139 Milano, Italy.
60-130.................. Ampicillin............ Do.
61-659.................. Erythromycin Delayed- Solvay
Release Tablets, Pharmaceuticals,
U.S.P., 250 Inc., 901 Sawyer Rd.,
milligrams (mg). Marietta, GA 30062.
61-818.................. Cephalexin Monohydrate IBI.
61-923.................. Amoxicillin Trihydrate Do.
62-052.................. Nystatin Ointment, Lemmon Co., 650
U.S.P.. Cathill Rd.,
Sellersville, PA
18960.
62-430.................. Bacitracin Zinc and Pharmafair, Inc., 110
Polymyxin B Sulfate Kennedy Dr.,
Ophthalmic Ointment, Hauppauge, NY 11788.
U.S.P..
62-449.................. Cephalothin Sodium.... IBI.
62-666.................. Cephalothin Sodium for Fujisawa USA, Inc.,
Injection, U.S.P., 1 Parkway North Center,
gram (g) and 2 g. Three Parkway North,
Deerfield, IL 60015-
2548
62-710.................. Cephalothin Sodium.... IBI.
62-747.................. Clindamycin Phosphate Fujusawa USA, Inc.
Injection, U.S.P.,
150 mg/milliliters
(mL).
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ANDA No. Drug Applicant
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80-041.................. Trisulfapyrimidines Solvay
Oral Suspension, Pharmaceuticals, Inc.
U.S.P., 0.5 g/5 mL.
80-921.................. Vitamin A Capsules, Lemmon Co.
U.S.P., 50,000 units.
83-993.................. Phendimetrazine Solvay
Tartrate Tablets, Pharmaceuticals, Inc.
U.S.P., 35 mg.
84-435.................. Meprobamate Tablets, Do.
U.S.P., 200 mg.
85-897.................. Phendimetrazine Do.
Tartrate Capsules,
U.S.P., 35 mg.
87-074.................. Diatrizoate Meglumine Mallinckrodt Medical,
and Diatriozoate Inc., P.O. Box 5840,
Sodium Injectin, St. Louis, MO 63134.
U.S.P..
87-113.................. Triamcinolone Solvay
Acetonide Cream, Pharmaceuticals, Inc.
U.S.P. 0.1%.
87-210.................. Reserpine, Hydralazine Do.
Hydrochloride, and
Hydrochlorothiazide
Tablets, U.S.P., 0.1
mg/25 mg/15 mg.
87-833.................. Prednisone Tablets, Roxane Laboratories,
U.S.P., 25 mg. Inc., P.O. Box 16532,
Columbus, OH 43216-
6532
88-071.................. Dexamethasone Sodium Pharmafair, Inc.
Phosphate Ophthalmic
Ointment, U.S.P.,
0.05%.
88-612.................. Phentermine Lemmon Co.
Hydrochloride
Capsules, U.S.P., 30
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 applications listed above, and all amendments and
supplements thereto, is hereby withdrawn, effective March 31, 1995.
Dated: February 16, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-5060 Filed 2-28-95; 8:45 am]
BILLING CODE 4160-01-F