[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Notices]
[Pages 50626-50627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24158]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0317]
Colgate-Palmolive Co., et al.; Withdrawal of Approval of 23 New
Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 23 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applications be withdrawn.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 G. 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 have requested that FDA withdraw approval of the
applications. The applicants have also, by request, waived their
opportunity for a hearing.
[[Page 50627]]
------------------------------------------------------------------------
NDA No. Drug Applicant
------------------------------------------------------------------------
6-615........ Veto Cream Deodorant........ Colgate-Palmolive Co., P.O.
Box 1343, 909 River Rd.,
Piscataway, NJ 08855-1343.
7-871........ Perazil Cream............... Burroughs Wellcome Co.,
3030 Cornwallis Rd., P.O.
Box 12700, Research
Triangle Park, NC 27709-
2700.
8-842........ Raudixin Tablets............ Apothecon, Bristol-Myers
Squibb Co., P.O. Box 4500,
Princeton, NJ 08543-4500.
10-653....... Disipal Tablets............. Riker Laboratories Inc., 3M
Pharmaceuticals, 270-3A-01
3M Center, St. Paul, MN
55144-1000.
12-026....... Apresoline-Esidrix Tablets.. Ciba Pharmaceuticals
Division, Ciba-Geigy
Corp., 556 Morris Ave.,
Summit, NJ 07901-1398.
12-402....... Ivadantin Injection......... Procter & Gamble
Pharmaceuticals,
Regulatory and Clinical
Development, Sharon Woods
Technical Center, 11370
Reed Hartman Hwy.,
Cincinnati, OH 45241-2422.
16-069....... Mepriam Tablets............. Lemmon Co., 650 Cathill
Rd., Sellersville, PA
18960.
16-379....... Locorten Cream.............. Ciba Pharmaceuticals
Division.
17-046....... Kaon-Cl/Koan-Cl 10 Tablets.. Savage Laboratories,
Division of Altana Inc.,
60 Baylis Rd., Melville,
NY 11747.
17-244....... Uticort Gel................. Parke-Davis Pharmaceutical
Research, Division of
Warner-Lambert Co., 2800
Plymouth Rd., Ann Arbor,
MI 48105.
17-739....... Monistat-Derm Lotion........ The R.W. Johnson
Pharmaceutical Research
Institute, Route 202, P.O.
Box 300, Raritan, NJ 08869-
0602.
17-941....... Sudafed 12-Hour Capsules.... Burroughs Wellcome Co.
18-004....... Hydroxyprogesterone Caproate Akorn Inc., P.O. Box 1220,
Injection. Decatur, IL 62525.
18-009....... Sarenin Injection........... Procter & Gamble
Pharmaceuticals.
18-075....... K-TimeKap Capsules.......... Ciba Pharmaceuticals
Division.
18-166....... Trasicor Capsules........... Do.
18-816....... Micatin Antifungal Powder... Advanced Care Products,
Ortho Pharmaceutical
Corp., J&J Research
Complex, Route 1 South and
Middleton Rd., North
Brunswick, NJ 08902-0724.
18-872....... Viskazide Tablets........... Sandoz Pharmaceuticals
Corp., 59 Route 10, East
Hanover, NJ 07936-1080.
19-208....... Actifed Capsules............ Burroughs Wellcome Co.
19-451....... Lopressor Chlorthalidone Ciba Pharmaceutials
Capsules. Division.
20-158....... Deracyn Tablets............. The Upjohn Co., U.S.
Pharmaceutical Regulatory
Affairs, 7000 Portage Rd.,
Kalamazoo, MI 49001-0199.
50-473....... Velosef Powder for Oral Apothecon.
Suspension.
50-474....... Velosef Capsules............ Do.
------------------------------------------------------------------------
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 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. 95-24158 Filed 9-28-95; 8:45 am]
BILLING CODE 4160-01-P