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Mylan Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 66 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 66 abbreviated new drug applications (ANDAs). The holders of the applications notified the agency in Start Printed Page 41030writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective September 5, 2001.

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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
61-755Ampicillin Capsules USP, 250 milligrams (mg) and 500 mg.Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504.
62-090Amoxicillin for Oral Suspension USP, 125 mg/5 milliliters (mL) and 250 mg/5 mL.Do.
62-928Clindamycin Phosphate Injection USP, 150 mg/mL.AstraZeneca, 725 Chesterbrook Blvd., Wayne, PA 19087-5677.
63-167Amikacin Sulfate Injection USP, 50 mg (base)/mL.Do.
63-169Amikacin Sulfate Injection USP, 250 mg (base)/mL.Do.
70-095Furosemide Injection USP, 10 mg/mL.Do.
70-096Furosemide Injection USP, 10 mg/mL.Do.
70-529Indomethacin Capsules USP, 25 mg.Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880.
70-530Indomethacin Capsules USP, 50 mg.Do.
70-645Metoclopramide Tablets, 10 mg.Do.
71-920Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mg.Do.
71-921Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mg.Do.
71-922Methyldopa and Hydrochlorothiazide Tablets USP,500 mg/30 mg.Do.
71-923Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mg.Do.
72-023Metaproterenol Sulfate Syrup USP, 10 mg/5 mL.Muro Pharmaceuticals, Inc., 890 East St., Tewksbury, MA 01876.
72-081Naloxone Hydrochloride (HCl) Injection USP, 0.02 mg/mL.AstraZeneca.
72-086Naloxone HCl Injection USP, 0.4 mg/mL.Do.
72-091Naloxone HCl Injection USP, 1 mg/mL.Do.
72-165Fenoprofen Tablets USP, 600 mg.Watson Laboratories, Inc.
72-293Fenoprofen Capsules USP, 300 mg.Do.
72-294Fenoprofen Capsules USP, 200 mg.Do.
72-372Duphalac (Lactulose Solution USP), 10 grams/15 mL.Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062.
73-062Loperamide HCl Oral Solution, 1 mg/5 mL.Watson Laboratories, Inc.
73-106Acetaminophen Suppositories USP, 120 mg.Able Laboratories, Inc.,6 Hollywood Ct., South Plainfield, NJ 07080.
73-107Acetaminophen Suppositories USP, 325 mg.Do.
73-108Acetaminophen Suppositories USP, 650 mg.Do.
73-120Albuterol Tablets USP, 2 mg.Medeva Pharmaceuticals, Inc., 3501 West Garry Ave., Santa Ana, CA 92704.
73-121Albuterol Tablets USP, 4 mg.Do.
73-165Albuterol Sulfate Syrup, 2 mg/5 mL.Watson Laboratories, Inc.
73-381Carbidopa and Levodopa Tablets USP, 10 mg/100 mg.Do.
73-382Carbidopa and Levodopa Tablets USP, 25 mg/100 mg.Do.
73-383Carbidopa and Levodopa Tablets USP, 25 mg/250 mg.Do.
73-651Piroxicam Capsules USP,10 mg and 20 mg.Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216.
74-156Gemfibrozil Tablets USP, 600 mg.Watson Laboratories, Inc.
74-199Alprazolam Tablets USP, 0.25 mg, 0.5 mg, and 1 mg.Roxane Laboratories, Inc.
74-319Naproxen Sodium Tablets USP.Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207.
74-570Acyclovir Capsules USP, 200 mg.Roxane Laboratories, Inc.
74-897Acyclovir Sodium for Injection, USP.Apothecon, Inc., P.O. Box 4500,Princeton, NJ 08543.
74-972Cimetidine Tablets USP, 100 mg.L. Perrigo Co.,515 Eastern Ave., Allegan, MI 49010.
80-109Sulfisoxazole Tablets USP, 500 mg.Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
80-782Prednisone Tablets USP, 5 mg.Do.
83-080Aquasol A (Vitamin A Capsules USP).AstraZeneca.
83-857Estratab Esterified Estrogens Tablets USP, 2.5 mg.Solvay Pharmaceuticals, Inc.
84-574Aminophylline Tablets, 100 mg.Impax Laboratories, Inc.
84-576Aminophylline Tablets, 200 mg.Do.
84-922Hydralazine HCl Tablets USP, 25 mg.Do.
85-171Glutethimide Tablets USP, 500 mg.Medeva Pharmaceuticals, Inc.
85-264Bronkodyl (Theophylline Capsules USP), 100 mg and 200 mg.Sanofi-Synthelabo, Inc., 90 Park Ave., 6th Fl., New York, NY 10016.
85-376Dexamethasone Tablets USP, 0.75 mg.Impax Laboratories, Inc.
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85-544Diethylpropion HCl Tablets USP, 25 mg.Medeva Pharmaceuticals, Inc.
85-864Amitriptyline HCl Tablets USP, 10 mg.Do.
85-935Amitriptyline HCl Tablets USP, 25 mg.Do.
85-936Amitriptyline HCl Tablets USP, 50 mg.Do.
86-335Amitriptyline HCl Tablets USP, 150 mg.Do.
86-336Amitriptyline HCl Tablets USP, 100 mg.Do.
86-337Amitriptyline HCl Tablets USP, 75 mg.Do.
87-156Fluonid (Fluocinolone Acetonide) Cream, 0.025%.Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623.
87-157Fluonid (Fluocinolone Acetonide) Ointment, 0.025%.Do.
88-075Amitriptyline HCl Tablets, 10 mg.Purepac Pharmaceutical Co.
88-076Amitriptyline HCl Tablets, 25 mg.Do.
88-077Amitriptyline HCl Tablets, 50 mg.Do.
88-078Amitriptyline HCl Tablets, 75 mg.Do.
88-079Amitriptyline HCl Tablets, 100 mg.Do.
88-215Penecort (Hydrocortisone) Gel, 1%.Allergan
88-217Penecort (Hydrocortisone) Ointment, 2.5%.Do.
89-495Hydrocortisone Lotion USP, 1%.Beta Dermaceuticals, Inc., P.O. Box 691106, San Antonio, TX 78269.

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 September 5, 2001.

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Dated: July 24, 2001.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

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[FR Doc. 01-19509 Filed 8-3-01; 8:45 am]