[Federal Register Volume 67, Number 28 (Monday, February 11, 2002)]
[Notices]
[Pages 6264-6265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0036]


Aventis Pharmaceuticals et al.; Withdrawal of Approval of 12 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 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withdrawn.

DATES: Effective March 13, 2002.

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

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 6265]]



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    NDA No.                  Drug                      Applicant
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8-102            Tace (chlorotrianisene).     Aventis Pharmaceuticals,
                                               399 Interpace Pkwy., P.O.
                                               Box 663, Parsippany, NJ
                                               07054.
9-925            Dyclone (dyclonine           AstraZeneca LP, 1800
                  hydrochloride (HCl))         Concord Pike, P.O. Box
                  Topical Solution, 0.5% and   8355, Wilmington, DE
                  1%.                          19803-8355.
11-444           Tace (chlorotrianisene)      Aventis Pharmaceuticals
                  Capsules, 25 milligrams
                  (mg).
14-322           Meprobamate Tablets, 200 mg  IMPAX Laboratories, Inc.,
                  and 400 mg.                  30831 Huntwood Ave.,
                                               Hayward, CA 94544.
16-235           Tace (chlorotrianisene)      Aventis Pharmaceuticals
                  Capsules, 72 mg.
17-829           Diprosone (betamethasone     Schering Corp., 2000
                  dipropionate) Aerosol.       Galloping Hill Rd.,
                                               Kenilworth, NJ 07033.
19-188           Gastrocrom (cromolyn         Celltech Pharmaceuticals,
                  sodium) Capsules.            Inc., 755 Jefferson Rd.,
                                               P.O. Box 31710,
                                               Rochester, NY 14603-1710.
19-399           Total Parenteral Nutrition   Abbott Laboratories, D-389
                  Electrolytes.                Bldg. AP30, 200 Abbott
                                               Park Rd., Abbott Park, IL
                                               60064-3537.
20-227           Normiflo (ardeparin sodium)  Pharmacia & Upjohn Co.,
                  Injection.                   7000 Portage Rd.,
                                               Kalamazoo, MI 49001-0199.
50-370           Ilotycin Gluceptate          Eli Lilly and Co., Lilly
                  (erythromycin gluceptate).   Corp. Center,
                                               Indianapolis, IN 46285.
50-579           Monocid (cefonicid sodium)   SmithKline Beecham
                  Injection.                   Pharmaceuticals, One
                                               Franklin Plaza, P.O. Box
                                               7929, Philadelphia, PA
                                               19101-7929.
50-581           Mefoxin (cefoxitin sodium)   Merck & Co., Inc., P.O.
                  Premixed IV Solution.        Box 4, BLA-20, West
                                               Point, PA 19486.
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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 in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
March 13, 2002.

    Dated: January 18, 2002.
Steven K. Galson,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 02-3199 Filed 2-8-02; 8:45 am]
BILLING CODE 4160-02-S