[Federal Register Volume 64, Number 184 (Thursday, September 23, 1999)]
[Notices]
[Pages 51546-51548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24720]
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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.
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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be withdrawn.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]]
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ANDA No. Drug Applicant
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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.
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[[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. 99-24720 Filed 9-22-99; 8:45 am]
BILLING CODE 4160-01-F
