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Mylan Pharmaceuticals et al.; Withdrawal of Approval of 34 Abbreviated New Drug Applications

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 34 abbreviated new drug applications (ANDAs). 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 22, 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.

ANDA No.DrugApplicant
61-530Penicillin V Potassium Tablets USP, 250 milligrams (mg) and 500 mg.Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310 Morgantown, WV 26504-4310.
61-829Ampicillin for Oral Suspension USP, 125 mg/5 milliliters (mL) and 250mg/5 mL.Do.
62-067Amoxicillin Capsules USP, 250 mg and 500 mgDo.
62-104Neomycyin Sulfate with Hydrocortisone Ointment USP, 0.35% and 1%.Clay-Park Laboratories, Inc., 1700 Bathgate Ave., Bronx, NY 10457.
62-280Nystatin and Triamcinolone Acetonide Ointment USPDo.
62-372Mezlin (sterile mezlocillin sodium)Bayer Corp. Pharmaceutical Division, 400 Morgan Lane, West Haven, CT 06516.
62-697Mezlin (sterile mezlocillin sodium)Do.
71-099Bromatapp ER (brompheniramine maleate/phenylpropanolamine hydrochloride (HCl)) Extended-Release Tablets, 12 mg/75 mg.Copley Pharmaceuticals, Inc., 25 John Rd. Canton, MA 02021.
71-551Flurazepam HCl Capsules USP, 30 mgPurepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207.
71-927Flurazepam HCl Capsules USP, 15 mgDo.
72-027Fentanyl Citrate and Droperidol InjectionAstraZeneca LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355.
72-070Nalbuphine HCl Injection USP, 10 mg/mLDo.
72-073Nalbuphine HCl Injection USP, 20 mg/mLDo.
72-921Prazosin HCl Capsules USP, 2 mgPurepac Pharmaceutical Co.
72-991Prazosin HCl Capsules USP, 1 mgDo.
72-992Prazosin HCl Capsules USP, 5 mgDo.
73-690Calcitonin-Salmon Injection, 200 international units/mLAstraZeneca LP.
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74-579Betamethasone Dipropionate Cream USP, 0.05% (base)Clay-Park Laboratories, Inc.
75-263Midazolam HCl Injection, 5 mg (base)/mLAstraZeneca LP.
75-348Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL.Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543-4500.
75-355Labetalol HCl Injection USP, 5 mg/mLDo.
75-620Midazolam HCl Injection, 1 mg (base)/mL and 5 mg (base)/mL.Do.
75-641Midazolam HCl Injection, 5 mg (base)/mLDo.
75-642Bisoprolol Fumarate and Hydrochlorothiazide TabletsDo.
75-707Famotidine Injection, 10 mg/mLDo.
75-708Famotidine Injection, 10 mg/mL (preservative free)Do.
83-115Niacin Tablets USP, 500 mgImpax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
84-968Nitrofurazone Ointment USP, 0.2%Clay-Park Laboratories, Inc.
85-130Nitrofurazone Topical Solution USP, 0.2%Do.
86-424Triple Sulfa Vaginal CreamAltana Inc., 60 Baylis Rd., Melville, NY 11747.
86-810Fluocinolone Acetonide Cream USP, 0.01%Clay-Park Laboratories, Inc.
86-811Fluocinolone Acetonide Cream USP, 0.025%Do.
89-784Meperidine HCl Injection USP, 50 mg/mLAstraZeneca LP.
89-788Meperidine HCl Injection USP, 1,000 mg/mLDo.

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 22, 2002.

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Dated: February 12, 2002.

Steven K. Galson,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. 02-4091 Filed 2-19-02; 8:45 am]