[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]



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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.

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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applications be withdrawn.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]]
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   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.                    
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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 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