[Federal Register Volume 59, Number 201 (Wednesday, October 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25908]
[[Page Unknown]]
[Federal Register: October 19, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0368]
The Upjohn Co., et al.; Withdrawal of Approval of Seven
Abbreviated Antibiotic Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of seven abbreviated antibiotic applications (AADA's). The holders of
the AADA's 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be withdrawn.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: November 18, 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 AADA's 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.
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AADA No. Drug Applicant
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61-651....................... Penicillin V The Upjohn Co.,
Potassium Tablets, 7000 Portage Rd.,
U.S.P., 500 Kalamazoo, MI
milligrams (mg). 499001-0199.
61-656....................... Penicillin V Do.
Potassium for Oral
Solution, U.S.P.,
125 mg/5
milliliters (mL)
and 250 mg/5 mL.
61-838....................... Penicillin G SmithKline Beecham
Potassium(nonsteril Pharmaceuticals,
e bulk, technical Four Falls
grade). Corporate Center,
Rt. 23 and
Woodmont Ave.,
P.O. Box 1510,
King of Prussia,
PA 19406.
62-158....................... Bacitracin Pharmaderm,
Ophthalmic Division of Altana
Ointment, U.S.P., Inc., 60 Baylis
500 units/gram (g). Rd., Melville, NY
11747.
62-440....................... Gentamicin Sulfate Pharmafair, Inc.,
Ophthalmic 110 Kennedy Dr.,
Solution, U.S.P., Hauppauge, NY
0.3%. 11788.
62-558....................... Erythromycin Do.
Ethylsuccinate Oral
Suspension, U.S.P.,
400 mg/5 mL.
62-799....................... Bacitracin Ointment, Combe Inc., 1101
U.S.P., 500 units/g. Westchester Ave.,
White Plains, NY
10604-3597.
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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 AADA's listed above, and all amendments and supplements
thereto, is hereby withdrawn, effective on November 18, 1994.
Dated: October 4, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 94-25908 Filed 10-18-94; 8:45 am]
BILLING CODE 4160-01-F