Human drugs: New drug applications— Beecham Laboratories et al.; approval withdrawn,

[Federal Register: September 23, 1999 (Volume 64, Number 184)]

[Notices]

[Page 51546-51548]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr23se99-81]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-4006]

Beecham Laboratories et al.; Withdrawal of Approval of 44 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 44 abbreviated new drug applications (ANDA's). 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

EFFECTIVE DATE: September 23, 1999. FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, 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.

[[Page 51547]]

ANDA No.

Drug

Applicant

60-680

Ampicillin for Oral Suspension, 125 milligrams (mg)/5

Beecham Laboratories, 1 Franklin Plaza, P.O. Box 7929, milliliters (mL) and 250 mg/5 mL.

Philadelphia, PA 19101-7929. 60-922

Neomycin Sulfate-Hydrocortisone Topical Ointment.

Teva Pharmaceuticals, USA, 1510 Delp Dr., Kulpsville, PA 19443. 61-598

Ampicillin Trihydrate Capsules USP, 250 mg and 500 mg.

Pharmacia & Upjohn, 7000 Portage Rd., Kalamazoo, MI 49001- 0199. 61-599

Ampicillin Trihydrate for Oral Suspension USP, 125 mg/5 mL and Do. 250 mg/5 mL. 61-934

Sterile Ampicillin Sodium USP.

Bristol-Myers Squibb Pharmaceutical Research Institute, P.O. Box 4000, Princeton, NJ 08543-4000. 61-935

Penicillin G Sodium for Injection USP, 5,000,000 units per Do. vial. 62-425

Bacitracin-Polymyxin B Sulfate-Neomycin Sulfate Topical

Blistex Inc., 1800 Swift Dr., Oak Brook, IL 60532-1574. Ointment. 62-595

Neomycin Sulfate-Triamcinolone Acetonide Cream.

Pharmaderm, Division of Altana Inc., 60 Baylis Rd., Melville, NY 11747. 62-600

Neomycin Sulfate-Triamcinolone Acetonide Cream.

E. Fougers & Co., Division of Altana Inc., 60 Baylis Rd., Melville, NY 11747. 62-608

Neomycin Sulfate-Tramcinolone Acetonide Ointment.

Do. 62-609

Neomycin B Sulfate and Triamcinolone Acetonide Ointment.

Savage Laboratories, Inc., Division of Altana Inc., 60 Baylis Rd., Melville, NY 11747. 71-497

Anticoagulant Citrate Dextrose Solution USP.

Miles, Inc., 800 Dwight Way, Berkeley, CA 94701-1986. 72-374

PORTALAC (Lactulose Solution USP) 10 g/15 mL.

Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062. 80-414

Lidocaine Hydrochloride Injection USP, 1% and 2%.

Miles, Inc. 80-415

Procaine Hydrochloride Injection USP, 1% and 2%.

Do. 80-570

Cyanocobalamin Injection USP, 1,000 micrograms (mcg)/mL.

Savage Laboratories, Inc. 80-982

Ergocalciferol Capsules USP.

Pharmacia & Upjohn. 81-274

Hydrocortisone Acetate Cream 1%.

Able Laboratories Inc., 6 Hollywood Ct., South Plainfield, NJ 07080. 84-059

Hydrocortisone Cream 1%

G&W Laboratories, Inc., 111 Coolidge St., South Plainfield, NJ 07080-3895. 84-438

Meprobamate Tablets USP, 400 mg.

Pharmavite Corp., 15451 San Fernando Mission Blvd., P.O. Box 9606, Mission Hills, CA 91346-9606. 84-463

Ethchlorvynol Capsules USP, 100, 200, 500, and 750 mg.

Banner Gelatine Products Corp., 4125 Premier Dr., P.O. Box 2210, High Point, NC 27261-2210. 84-573

DERMACORT (Hydrocortisone Lotion USP) 0.5%.

Solvay Pharmaceuticals, Inc. 84-662

Prednisone Tablets USP, 5 mg.

Pharmavite Corp. 84-663

Reserpine Tablets USP, 0.25 mg.

Do. 84-664

Prednisolone Tablets USP, 5 mg.

Do. 84-693

Prophoxyphene Hydrochloride Capsules USP, 32 mg and 65 mg. Do. 84-707

Triamcinolone Tablets, 8 mg.

Roxane Laboratories, Inc., P.O. 16532, Columbus, OH 43216- 6532. 84-709

Triamcinolone Tablets, 4 mg.

Do. 84-991

DEXONE (Dexamethasone Tablets USP) 0.5 mg.

Solvay Pharmaceuticals, Inc. 84-992

DEXONE (Dexamethasone Tablets USP) 4 mg.

Do. 84-993

DEXONE (Dexamethasone Tablets USP) 0.75 mg.

Do. 85-024

Triproldine Hydrochloride and Pseudophedrine Hydrochloride MD Pharmaceuticals, Inc., 3501 W. Garry Ave., Santa Ana, CA Tablets, 2.5 mg/60 mg.

92704. 85-134

Acetaminophen Tablets, 325 mg and Oxycodone/Acetaminophen Bristol-Myers Squibb Co., Pharmaceutical Group, P.O. Box 4755, Tablets (Oxycodone Hydrochloride 4.5 mg, Oxycodone

Syracuse, NY 13221-4755. Terephthalate 0.38 mg, Acetaminophen 325 mg). 85-685

PROVAL #3 (Acetaminophen and Codeine Phosphate) Capsules, 325 Solvay Pharmaceuticals, Inc. mg/30 mg. 85-893

UNIPRES (Reserpine, Hydralazine Hydrochloride, and

Do. Hydrochlorothiazine) Tablets (peach) 0.1/25/15 mg. 85-999

ORASONE (Prednisone Tablets USP) 50 mg.

Do. 86-296

Folic Acid 1 mg.

Vintage Pharmaceuticals, Inc., 3241 Woodpark Blvd., Charlotte, NC 28206. 86-462

DERMACORT (Hydrocortisone Lotion USP) 1%.

Solvay Pharmaceuticals, Inc. 87-213

Hydralazine Hydrochloride and Hydrochlorothiazide Capsules, 50 Do. mg/50 mg. 87-228

Chloroquine Phosphate Tablets.

MD Pharmaceuticals, Inc. 87-566

Cyproheptadine Hydrochloride Tablets, 4 mg.

Do. 87-608

Hydralazine Hydrochloride and Hydrochlorothiazide Capsules 25 Solvay Pharmaceuticals, Inc. mg/25 mg. 88-376

Reserpine, Hydralazine Hydrochloride, and Hydrochlorothiazide Do. Tablets USP, 0.1 mg/25 mg/15 mg. 89-913

Triamcinolone Acetonide Ointment USP, 0.5%.

Alpharma, U.S. Pharmaceuticals Division, 333 Cassell Dr., suite 3500, Baltimore, MD 21224.

[[Page 51548]]

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 23, 1999.

Dated: September 8, 1999. Janet Woodcock Director, Center for Drug Evaluation and Research.

[FR Doc. 99-24720Filed9-22-99; 8:45 am]

BILLING CODE 4160-01-F