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Aventis Pharmaceuticals et al.; Withdrawal of Approval of 12 New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 12 new drug applications (NDAs). 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 March 13, 2002.

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Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

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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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NDA No.DrugApplicant
8-102Tace (chlorotrianisene).Aventis Pharmaceuticals, 399 Interpace Pkwy., P.O. Box 663, Parsippany, NJ 07054.
9-925Dyclone (dyclonine hydrochloride (HCl)) Topical Solution, 0.5% and 1%.AstraZeneca LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355.
11-444Tace (chlorotrianisene) Capsules, 25 milligrams (mg).Aventis Pharmaceuticals
14-322Meprobamate Tablets, 200 mg and 400 mg.IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
16-235Tace (chlorotrianisene) Capsules, 72 mg.Aventis Pharmaceuticals
17-829Diprosone (betamethasone dipropionate) Aerosol.Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
19-188Gastrocrom (cromolyn sodium) Capsules.Celltech Pharmaceuticals, Inc., 755 Jefferson Rd., P.O. Box 31710, Rochester, NY 14603-1710.
19-399Total Parenteral Nutrition Electrolytes.Abbott Laboratories, D-389 Bldg. AP30, 200 Abbott Park Rd., Abbott Park, IL 60064-3537.
20-227Normiflo (ardeparin sodium) Injection.Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199.
50-370Ilotycin Gluceptate (erythromycin gluceptate).Eli Lilly and Co., Lilly Corp. Center, Indianapolis, IN 46285.
50-579Monocid (cefonicid sodium) Injection.SmithKline Beecham Pharmaceuticals, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929.
50-581Mefoxin (cefoxitin sodium) Premixed IV Solution.Merck & Co., Inc., P.O. Box 4, BLA-20, West Point, PA 19486.

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 in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective March 13, 2002.

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Dated: January 18, 2002.

Steven K. Galson,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. 02-3199 Filed 2-8-02; 8:45 am]