[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Notices]
[Pages 50627-50628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24156]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0319]
Roche Pharmaceutical Inc., et al.; Withdrawal of Approval of 13
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 13 new drug applications (NDA's). The holders of the NDA's notified
the agency in writing that the drug products were no longer being
marketed under the NDA and requested that the approval of the
applications be withdrawn.
EFFECTIVE DATE: September 29, 1995.
FOR FURTHER INFORMATION CONTACT: Nancy Maizel, Center for Drug
Evaluation and Research (HFD-53), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2623.
SUPPLEMENTARY INFORMATION: The holders of the NDA's listed below have
informed FDA that these drug products are no longer being marketed
under the NDA and requested that FDA withdraw approval of the
applications. The applicants have also, by request, waived their
opportunity for a hearing.
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NDA No. Drug Applicant
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8-414........ Gantrisin Ophthalmic Roche Pharmaceuticals,
Ointment. Division of Hoffmann-La
Roche Inc., 340 Kingsland
St., Nutley, NJ 07110-
1199.
18-996....... Actifed 12-Hour Capsules.... Burroughs Wellcome Co.,
3030 Cornwallis Rd., P.O.
Box 12700, Research
Triangle Park, NC 27709-
2700.
50-102....... Dynapen for Injection....... Apothecon, Bristol-Myers
Squibb Co., P.O. Box 4500,
Princeton, NJ 08543-4500.
50-117....... Staphcillin Injection....... Do.
50-118....... Prostaphlin Capsules........ Do.
50-167....... Polysporin Aerosol Spray.... Burroughs Wellcome Co.
50-176....... Neosporin Cream............. Do.
50-191....... Tegopen Capsules............ Apothecon.
[[Page 50628]]
50-192....... Tegopen Powder for Oral Do.
Solution.
50-194....... Prostaphlin Powder for Oral Do.
Solution.
50-195....... Prostaphlin (Oxacillin Apothecon.
Sodium) for Injection.
50-308....... Polycillin (Ampicillin) Do.
Powder for Oral Solution.
50-337....... Dynapen for Oral Suspension. Do.
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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 of the Center for Drug Evaluation and Research (21 CFR 5.82),
approval of the NDA's listed above, and all amendments and supplements
thereto, is hereby withdrawn, effective September 29, 1995.
Dated: September 21, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-24156 Filed 9-28-95; 8:45 am]
BILLING CODE 4160-01-P
