66 FR 151 pgs. 41029-41031 - Mylan Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 66 Abbreviated New Drug Applications
Type: NOTICEVolume: 66Number: 151Pages: 41029 - 41031
Docket number: [Docket No. 01N-0317]
FR document: [FR Doc. 01-19509 Filed 8-3-01; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0317]
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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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.
[FR Doc. 01-19509 Filed 8-3-01; 8:45 am]
BILLING CODE 4160-01-S