01-19509. Mylan Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 66 Abbreviated New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES:

Effective September 5, 2001.

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.

ANDA No.	Drug	Applicant
61-755	Ampicillin Capsules USP, 250 milligrams (mg) and 500 mg.	Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504.
62-090	Amoxicillin for Oral Suspension USP, 125 mg/5 milliliters (mL) and 250 mg/5 mL.	Do.
62-928	Clindamycin Phosphate Injection USP, 150 mg/mL.	AstraZeneca, 725 Chesterbrook Blvd., Wayne, PA 19087-5677.
63-167	Amikacin Sulfate Injection USP, 50 mg (base)/mL.	Do.
63-169	Amikacin Sulfate Injection USP, 250 mg (base)/mL.	Do.
70-095	Furosemide Injection USP, 10 mg/mL.	Do.
70-096	Furosemide Injection USP, 10 mg/mL.	Do.
70-529	Indomethacin Capsules USP, 25 mg.	Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880.
70-530	Indomethacin Capsules USP, 50 mg.	Do.
70-645	Metoclopramide Tablets, 10 mg.	Do.
71-920	Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mg.	Do.
71-921	Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mg.	Do.
71-922	Methyldopa and Hydrochlorothiazide Tablets USP,500 mg/30 mg.	Do.
71-923	Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mg.	Do.
72-023	Metaproterenol Sulfate Syrup USP, 10 mg/5 mL.	Muro Pharmaceuticals, Inc., 890 East St., Tewksbury, MA 01876.
72-081	Naloxone Hydrochloride (HCl) Injection USP, 0.02 mg/mL.	AstraZeneca.
72-086	Naloxone HCl Injection USP, 0.4 mg/mL.	Do.
72-091	Naloxone HCl Injection USP, 1 mg/mL.	Do.
72-165	Fenoprofen Tablets USP, 600 mg.	Watson Laboratories, Inc.
72-293	Fenoprofen Capsules USP, 300 mg.	Do.
72-294	Fenoprofen Capsules USP, 200 mg.	Do.
72-372	Duphalac (Lactulose Solution USP), 10 grams/15 mL.	Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062.
73-062	Loperamide HCl Oral Solution, 1 mg/5 mL.	Watson Laboratories, Inc.
73-106	Acetaminophen Suppositories USP, 120 mg.	Able Laboratories, Inc.,6 Hollywood Ct., South Plainfield, NJ 07080.
73-107	Acetaminophen Suppositories USP, 325 mg.	Do.
73-108	Acetaminophen Suppositories USP, 650 mg.	Do.
73-120	Albuterol Tablets USP, 2 mg.	Medeva Pharmaceuticals, Inc., 3501 West Garry Ave., Santa Ana, CA 92704.
73-121	Albuterol Tablets USP, 4 mg.	Do.
73-165	Albuterol Sulfate Syrup, 2 mg/5 mL.	Watson Laboratories, Inc.
73-381	Carbidopa and Levodopa Tablets USP, 10 mg/100 mg.	Do.
73-382	Carbidopa and Levodopa Tablets USP, 25 mg/100 mg.	Do.
73-383	Carbidopa and Levodopa Tablets USP, 25 mg/250 mg.	Do.
73-651	Piroxicam Capsules USP,10 mg and 20 mg.	Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216.
74-156	Gemfibrozil Tablets USP, 600 mg.	Watson Laboratories, Inc.
74-199	Alprazolam Tablets USP, 0.25 mg, 0.5 mg, and 1 mg.	Roxane Laboratories, Inc.
74-319	Naproxen Sodium Tablets USP.	Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207.
74-570	Acyclovir Capsules USP, 200 mg.	Roxane Laboratories, Inc.
74-897	Acyclovir Sodium for Injection, USP.	Apothecon, Inc., P.O. Box 4500,Princeton, NJ 08543.
74-972	Cimetidine Tablets USP, 100 mg.	L. Perrigo Co.,515 Eastern Ave., Allegan, MI 49010.
80-109	Sulfisoxazole Tablets USP, 500 mg.	Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
80-782	Prednisone Tablets USP, 5 mg.	Do.
83-080	Aquasol A (Vitamin A Capsules USP).	AstraZeneca.
83-857	Estratab Esterified Estrogens Tablets USP, 2.5 mg.	Solvay Pharmaceuticals, Inc.
84-574	Aminophylline Tablets, 100 mg.	Impax Laboratories, Inc.
84-576	Aminophylline Tablets, 200 mg.	Do.
84-922	Hydralazine HCl Tablets USP, 25 mg.	Do.
85-171	Glutethimide Tablets USP, 500 mg.	Medeva Pharmaceuticals, Inc.
85-264	Bronkodyl (Theophylline Capsules USP), 100 mg and 200 mg.	Sanofi-Synthelabo, Inc., 90 Park Ave., 6th Fl., New York, NY 10016.
85-376	Dexamethasone Tablets USP, 0.75 mg.	Impax Laboratories, Inc.
85-544	Diethylpropion HCl Tablets USP, 25 mg.	Medeva Pharmaceuticals, Inc.
85-864	Amitriptyline HCl Tablets USP, 10 mg.	Do.
85-935	Amitriptyline HCl Tablets USP, 25 mg.	Do.
85-936	Amitriptyline HCl Tablets USP, 50 mg.	Do.
86-335	Amitriptyline HCl Tablets USP, 150 mg.	Do.
86-336	Amitriptyline HCl Tablets USP, 100 mg.	Do.
86-337	Amitriptyline HCl Tablets USP, 75 mg.	Do.
87-156	Fluonid (Fluocinolone Acetonide) Cream, 0.025%.	Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623.
87-157	Fluonid (Fluocinolone Acetonide) Ointment, 0.025%.	Do.
88-075	Amitriptyline HCl Tablets, 10 mg.	Purepac Pharmaceutical Co.
88-076	Amitriptyline HCl Tablets, 25 mg.	Do.
88-077	Amitriptyline HCl Tablets, 50 mg.	Do.
88-078	Amitriptyline HCl Tablets, 75 mg.	Do.
88-079	Amitriptyline HCl Tablets, 100 mg.	Do.
88-215	Penecort (Hydrocortisone) Gel, 1%.	Allergan
88-217	Penecort (Hydrocortisone) Ointment, 2.5%.	Do.
89-495	Hydrocortisone 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.

Dated: July 24, 2001.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.