67 FR 34 pgs. 7702-7703 - Mylan Pharmaceuticals et al.; Withdrawal of Approval of 34 Abbreviated New Drug Applications
Type: NOTICEVolume: 67Number: 34Pages: 7702 - 7703
Docket number: [Docket No. 02N-0035]
FR document: [FR Doc. 02-4091 Filed 2-19-02; 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. 02N-0035]
Mylan Pharmaceuticals et al.; Withdrawal of Approval of 34 Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Effective March 22, 2002.
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 |
|---|---|---|
| 61-530 | Penicillin 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. |
| 61-829 | Ampicillin for Oral Suspension USP, 125 mg/5 milliliters (mL) and 250mg/5 mL. | Do. |
| 62-067 | Amoxicillin Capsules USP, 250 mg and 500 mg | Do. |
| 62-104 | Neomycyin Sulfate with Hydrocortisone Ointment USP, 0.35% and 1%. | Clay-Park Laboratories, Inc., 1700 Bathgate Ave., Bronx, NY 10457. |
| 62-280 | Nystatin and Triamcinolone Acetonide Ointment USP | Do. |
| 62-372 | Mezlin (sterile mezlocillin sodium) | Bayer Corp. Pharmaceutical Division, 400 Morgan Lane, West Haven, CT 06516. |
| 62-697 | Mezlin (sterile mezlocillin sodium) | Do. |
| 71-099 | Bromatapp ER (brompheniramine maleate/phenylpropanolamine hydrochloride (HCl)) Extended-Release Tablets, 12 mg/75 mg. | Copley Pharmaceuticals, Inc., 25 John Rd. Canton, MA 02021. |
| 71-551 | Flurazepam HCl Capsules USP, 30 mg | Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207. |
| 71-927 | Flurazepam HCl Capsules USP, 15 mg | Do. |
| 72-027 | Fentanyl Citrate and Droperidol Injection | AstraZeneca LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355. |
| 72-070 | Nalbuphine HCl Injection USP, 10 mg/mL | Do. |
| 72-073 | Nalbuphine HCl Injection USP, 20 mg/mL | Do. |
| 72-921 | Prazosin HCl Capsules USP, 2 mg | Purepac Pharmaceutical Co. |
| 72-991 | Prazosin HCl Capsules USP, 1 mg | Do. |
| 72-992 | Prazosin HCl Capsules USP, 5 mg | Do. |
| 73-690 | Calcitonin-Salmon Injection, 200 international units/mL | AstraZeneca LP. |
| 74-579 | Betamethasone Dipropionate Cream USP, 0.05% (base) | Clay-Park Laboratories, Inc. |
| 75-263 | Midazolam HCl Injection, 5 mg (base)/mL | AstraZeneca LP. |
| 75-348 | Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL. | Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543-4500. |
| 75-355 | Labetalol HCl Injection USP, 5 mg/mL | Do. |
| 75-620 | Midazolam HCl Injection, 1 mg (base)/mL and 5 mg (base)/mL. | Do. |
| 75-641 | Midazolam HCl Injection, 5 mg (base)/mL | Do. |
| 75-642 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets | Do. |
| 75-707 | Famotidine Injection, 10 mg/mL | Do. |
| 75-708 | Famotidine Injection, 10 mg/mL (preservative free) | Do. |
| 83-115 | Niacin Tablets USP, 500 mg | Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. |
| 84-968 | Nitrofurazone Ointment USP, 0.2% | Clay-Park Laboratories, Inc. |
| 85-130 | Nitrofurazone Topical Solution USP, 0.2% | Do. |
| 86-424 | Triple Sulfa Vaginal Cream | Altana Inc., 60 Baylis Rd., Melville, NY 11747. |
| 86-810 | Fluocinolone Acetonide Cream USP, 0.01% | Clay-Park Laboratories, Inc. |
| 86-811 | Fluocinolone Acetonide Cream USP, 0.025% | Do. |
| 89-784 | Meperidine HCl Injection USP, 50 mg/mL | AstraZeneca LP. |
| 89-788 | Meperidine HCl Injection USP, 1,000 mg/mL | Do. |
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.
Dated: February 12, 2002.
Steven K. Galson,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 02-4091 Filed 2-19-02; 8:45 am]
BILLING CODE 4160-01-S