[Federal Register Volume 59, Number 149 (Thursday, August 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18971]
[[Page Unknown]]
[Federal Register: August 4, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0287]
Glaxo, Inc., et al.; Withdrawal of Approval of 13 Abbreviated
Antibiotic Applications and 2 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 13 abbreviated antibiotic applications (AADA's) and 2 abbreviated
new drug applications (ANDA's). The holders of the applications
notified the agency in writing that the drug products were no being
longer marketed and requested that the approval of the applications be
withdrawn.
EFFECTIVE DATE: September 6, 1994.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug
Evaluation and Research (HFD-360), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1038.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table below have informed FDA that these drug products are no
longer being marketed and have requested that FDA withdraw approval of
the applications. The applicants have also, by request, waived their
opportunity for a hearing.
------------------------------------------------------------------------
Application no. Drug Applicant
------------------------------------------------------------------------
AADA 61-231 Crystalline Penicillin G Glaxo, Inc., Five Moore
Potassium (bulk). Dr., P.O. Box 13358,
Research Triangle Park,
NC 27709.
AADA 61-232 Crystalline Penicillin G Do.
Sodium (bulk).
AADA 61-324 Penicillin G Procaine Do.
(bulk).
AADA 61-491 Penicillin G Procaine Do.
Type ``A'' (bulk).
AADA 61-705 Tetracycline The Upjohn Co., 7000
Hydrochloride Tablets, Portage Rd., Kalamazoo,
U.S.P., 250 milligrams MI 49001.
(mg) and 500 mg.
AADA 61-743 Erythromycin Stearate Purepac Pharmaceutical
Tablets, U.S.P., 250 mg. Co., 200 Elmora Ave.,
Elizabeth, NJ 07207.
AADA 61-945 Sterile Penicillin G Glaxo, Inc.
Potassium Buffered
(bulk).
AADA 629-053 Rifampin, U.S.P., Marion Merrill Dow,
(nonsterile bulk). Inc., Marion Park Dr.,
Kansas City, MO 64134-
0627.
AADA 62-213 Sterile Penicillin G Glaxo, Inc.
Sodium Buffered (bulk).
AADA 62-297 Ampicillin for Oral Bristol-Myers Co., P.O.
Squibb, Box 4755, Syracuse, NY
Suspension,U.S.P., 125 13221-4755.
mg/5 milliliters (mL)
and 250 mg/5 mL.
AADA 62-399 Neomycin and Polymyxin B Pharmafair, Inc., 110
Sulfates and Kennedy Dr., Hauppauge,
Hydrocortisone Otic NY 11788.
Suspension, U.S.P..
AADA 62-404 Sterile Cephalothin Glaxo, Inc.
Sodium, U.S.P. (bulk).
AADA 62-435 Cephalothin Sodium for Do.
Injection, U.S.P..
ANDA 88-101 Naphazoline Pharmafair, Inc.
Hydrochloride
Ophthalmic Solution,
U.S.P., 0.1%.
ANDA 88-230 Tropicamide Ophthalmic Do.
Solution, U.S.P., 1%.
------------------------------------------------------------------------
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 above, and all amendments and
supplements thereto, is hereby withdrawn, effective September 6, 1994.
Dated: July 26, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 94-18971 Filed 8-3-94; 8:45 am]
BILLING CODE 4160-01-F
