[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Notices]
[Page 50628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24157]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0318]


Searle, et al.; Withdrawal of Approval of 17 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 17 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applications be withdrawn.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.

------------------------------------------------------------------------
   NDA No.                 Drug                       Applicant         
------------------------------------------------------------------------
2-386........  Aminophyllin Tablets........  Searle, 4901 Searle Pkwy., 
                                              Skokie, IL 60077          
3-205........  Pantholin Tablets...........  Lilly Research             
                                              Laboratories, Division of 
                                              Eli Lilly and Co., Lilly  
                                              Corporate Center,         
                                              Indianapolis, IN 46285.   
6-917........  Gantrisin Injection.........  Hoffmann-La Roche Inc.,    
                                              Roche Pharmaceuticals, 340
                                              Kingsland St., Nutley, NJ 
                                              07110-1199.               
8-867........  Rauwiloid Tablets...........  3M Pharmaceuticals, 3M     
                                              Center, St. Paul, MN 55144-
                                              1000.                     
9-078........  Parsidol Tablets............  Parke-Davis Pharmaceutical 
                                              Research, 2800 Plymouth   
                                              Rd., Ann Arbor, MI 48105. 
9-299........  Hyperloid Tablets...........  Person & Covey Inc., P.O.  
                                              Box 25018, 616 Allen Ave.,
                                              Glendale, CA 91221-5018.  
11-045.......  Milprem Tablets.............  Wallace Laboratories,      
                                              Division of Carter-Wallace
                                              Inc., 301B College Rd.    
                                              East, Princeton, NJ 08540.
11-110.......  Actidil Tablets.............  Burroughs Wellcome Co.,    
                                              3030 Cornwallis Rd., P.O. 
                                              Box 12700, Research       
                                              Triangle Park, NC 27709-  
                                              2700.                     
11-496.......  Actidil Syrup...............      Do.                    
11-535.......  Equanil Meprobamate           Wyeth-Ayerst Laboratories, 
                Suspension.                   P.O. Box 8299,            
                                              Philadelphia, PA 19101-   
                                              8299.                     
11-876.......  Fedrazil Tablets............  Burroughs Wellcome Co.     
17-528.......  Uticort Lotion..............  Parke-Davis Pharmaceutical 
                                              Research.                 
17-917.......  Duraquin Tablets............  Warner Chilcott            
                                              Laboratories, 201 Tabor   
                                              Rd., Morris Plains, NJ    
                                              07950.                    
18-375.......  Turgex Bacteriostatic Skin    Xttrium Laboratories Inc., 
                Cleanser (Aerosol).           415 West Pershing Rd.,    
                                              Chicago, IL 60609.        
19-055.......  Turgex Bacteriostatic Skin        Do.                    
                Cleanser (Emulsion).                                    
50-019.......  Penbritin Ampicillin Drops..  Wyeth-Ayerst Laboratories. 
50-355.......  Coly-Mycin S Oral Suspension  Parke-Davis Pharmaceutical 
                                              Research.                 
------------------------------------------------------------------------

    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 2, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-24157 Filed 9-28-95; 8:45 am]
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