Federal Register: August 6, 2001 (Volume 66, Number 151)NoticesPage 41029-41031From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr06au01-82

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 01N-0317Mylan 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

[Page 41030]writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Mylan USP, 250 milligrams Pharmaceuticals, (mg) and 500 mg.. Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. 62-090...................... Amoxicillin for Oral Do. Suspension USP, 125 mg/5 milliliters (mL) and 250 mg/5 mL.. 62-928...................... Clindamycin

AstraZeneca, 725 Phosphate Injection Chesterbrook Blvd., USP, 150 mg/mL.. Wayne, PA 19087- 5677. 63-167...................... Amikacin Sulfate Do. Injection USP, 50 mg (base)/mL.. 63-169...................... Amikacin Sulfate Do. Injection USP, 250 mg (base)/mL.. 70-095...................... Furosemide Injection Do. USP, 10 mg/mL.. 70-096...................... Furosemide Injection Do. USP, 10 mg/mL.. 70-529...................... Indomethacin

Watson Laboratories, Capsules USP, 25 Inc., 311 Bonnie mg..

Circle, Corona, CA 92880. 70-530...................... Indomethacin

Do. Capsules USP, 50 mg.. 70-645...................... Metoclopramide

Do. Tablets, 10 mg.. 71-920...................... Methyldopa and

Do. Hydrochlorothiazide Tablets USP, 250 mg/ 15 mg.. 71-921...................... Methyldopa and

Do. Hydrochlorothiazide Tablets USP, 250 mg/ 25 mg.. 71-922...................... Methyldopa and

Do. Hydrochlorothiazide Tablets USP,500 mg/ 30 mg.. 71-923...................... Methyldopa and

Do. Hydrochlorothiazide Tablets USP, 500 mg/ 50 mg.. 72-023...................... Metaproterenol

Muro Sulfate Syrup USP, Pharmaceuticals, 10 mg/5 mL..

Inc., 890 East St., Tewksbury, MA 01876. 72-081...................... Naloxone

AstraZeneca. Hydrochloride (HCl) Injection USP, 0.02 mg/mL.. 72-086...................... Naloxone HCl

Do. Injection USP, 0.4 mg/mL.. 72-091...................... Naloxone HCl

Do. Injection USP, 1 mg/ mL.. 72-165...................... Fenoprofen Tablets Watson Laboratories, USP, 600 mg..

Inc. 72-293...................... Fenoprofen Capsules Do. USP, 300 mg.. 72-294...................... Fenoprofen Capsules Do. USP, 200 mg.. 72-372...................... Duphalac (Lactulose Solvay Solution USP), 10 Pharmaceuticals, grams/15 mL..

Inc., 901 Sawyer Rd., Marietta, GA 30062. 73-062...................... Loperamide HCl Oral Watson Laboratories, Solution, 1 mg/5 Inc. mL.. 73-106...................... Acetaminophen

Able Laboratories, Suppositories USP, Inc.,6 Hollywood 120 mg..

Ct., South Plainfield, NJ 07080. 73-107...................... Acetaminophen

Do. Suppositories USP, 325 mg.. 73-108...................... Acetaminophen

Do. Suppositories USP, 650 mg.. 73-120...................... Albuterol Tablets Medeva USP, 2 mg..

Pharmaceuticals, Inc., 3501 West Garry Ave., Santa Ana, CA 92704. 73-121...................... Albuterol Tablets Do. USP, 4 mg.. 73-165...................... Albuterol Sulfate Watson Laboratories, Syrup, 2 mg/5 mL.. Inc. 73-381...................... Carbidopa and

Do. Levodopa Tablets USP, 10 mg/100 mg.. 73-382...................... Carbidopa and

Do. Levodopa Tablets USP, 25 mg/100 mg.. 73-383...................... Carbidopa and

Do. Levodopa Tablets USP, 25 mg/250 mg.. 73-651...................... Piroxicam Capsules Roxane Laboratories, USP,10 mg and 20 Inc., P.O. Box mg..

16532, Columbus, OH 43216. 74-156...................... Gemfibrozil Tablets Watson Laboratories, USP, 600 mg..

Inc. 74-199...................... Alprazolam Tablets Roxane Laboratories, USP, 0.25 mg, 0.5 Inc. mg, and 1 mg.. 74-319...................... Naproxen Sodium Purepac Tablets USP..

Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207. 74-570...................... Acyclovir Capsules Roxane Laboratories, USP, 200 mg..

Inc. 74-897...................... Acyclovir Sodium for Apothecon, Inc., Injection, USP.. P.O. Box 4500,Princeton, NJ 08543. 74-972...................... Cimetidine Tablets L. Perrigo Co.,515 USP, 100 mg..

Eastern Ave., Allegan, MI 49010. 80-109...................... Sulfisoxazole

Impax Laboratories, Tablets USP, 500 Inc., 30831 mg..

Huntwood Ave., Hayward, CA 94544. 80-782...................... Prednisone Tablets Do. USP, 5 mg.. 83-080...................... Aquasol A (Vitamin A AstraZeneca. Capsules USP).. 83-857...................... Estratab Esterified Solvay Estrogens Tablets Pharmaceuticals, USP, 2.5 mg..

Inc. 84-574...................... Aminophylline

Impax Laboratories, Tablets, 100 mg.. Inc. 84-576...................... Aminophylline

Do. Tablets, 200 mg.. 84-922...................... Hydralazine HCl Do. Tablets USP, 25 mg.. 85-171...................... Glutethimide Tablets Medeva USP, 500 mg..

Pharmaceuticals, Inc. 85-264...................... Bronkodyl

Sanofi-Synthelabo, (Theophylline

Inc., 90 Park Ave., Capsules USP), 100 6th Fl., New York, mg and 200 mg.. NY 10016. 85-376...................... Dexamethasone

Impax Laboratories, Tablets USP, 0.75 Inc. mg..

[Page 41031]

85-544...................... Diethylpropion HCl Medeva Tablets USP, 25 mg.. Pharmaceuticals, Inc. 85-864...................... Amitriptyline HCl Do. Tablets USP, 10 mg.. 85-935...................... Amitriptyline HCl Do. Tablets USP, 25 mg.. 85-936...................... Amitriptyline HCl Do. Tablets USP, 50 mg.. 86-335...................... Amitriptyline HCl Do. Tablets USP, 150 mg.. 86-336...................... Amitriptyline HCl Do. Tablets USP, 100 mg.. 86-337...................... Amitriptyline HCl Do. Tablets USP, 75 mg.. 87-156...................... Fluonid

Allergan, 2525 (Fluocinolone

Dupont Dr., P.O. Acetonide) Cream, Box 19534, Irvine, 0.025%..

CA 92623. 87-157...................... Fluonid

Do. (Fluocinolone Acetonide) Ointment, 0.025%.. 88-075...................... Amitriptyline HCl Purepac Tablets, 10 mg.. Pharmaceutical Co. 88-076...................... Amitriptyline HCl Do. Tablets, 25 mg.. 88-077...................... Amitriptyline HCl Do. Tablets, 50 mg.. 88-078...................... Amitriptyline HCl Do. Tablets, 75 mg.. 88-079...................... Amitriptyline HCl Do. Tablets, 100 mg.. 88-215...................... Penecort

Allergan (Hydrocortisone) Gel, 1%.. 88-217...................... Penecort

Do. (Hydrocortisone) Ointment, 2.5%.. 89-495...................... Hydrocortisone

Beta Dermaceuticals, Lotion USP, 1%.. 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.

FR Doc. 01-19509Filed8-3-01; 8:45 amBILLING CODE 4160-01-S