[Federal Register Volume 60, Number 97 (Friday, May 19, 1995)]
[Notices]
[Page 26892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12295]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0127]


Roussel Corp., et al.; Withdrawal of Approval of 16 Abbreviated 
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 16 abbreviated new drug applications (ANDA's). The holders of the 
ANDA'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withdrawn.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: June 19, 1995.

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 ANDA'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.

                                                                        
------------------------------------------------------------------------
        ANDA no.                   Drug                  Applicant      
------------------------------------------------------------------------
62-830.................  Sterile Cefazolin        Roussel Corp., 95     
                          Sodium, U.S.P. (bulk).   Chestnut Ridge Rd.,  
                                                   P.O. Box 30,         
                                                   Montvale, NJ 07645.  
70-662.................  Diazepam Injection,      Fujisawa              
                          U.S.P., 5 milligrams     Pharmaceutical Co.,  
                          (mg)/milliliter (mL).    Parkway North Center,
                                                   Three Parkway North, 
                                                   Deerfield, IL 60015- 
                                                   2548.                
80-517.................  Prednisolone Sodium      Steris Laboratories,  
                          Phosphate Injection,     Inc., 620 North 51st 
                          U.S.P., 20 mg/mL.        Ave., Phoenix, AZ    
                                                   85043-4705.          
80-702.................  Vitamin A Palmitate      Banner Pharmacaps,    
                          Capsules, EQ 50,000      Inc., 1111 Jefferson 
                          Units Base.              Ave., Elizabeth, NJ  
                                                   07207.               
83-531.................  Dimenhydrinate           Steris Laboratories,  
                          Injection, U.S.P., 50    Inc.                 
                          mg/mL.                                        
83-593.................  Chlorpheniramine         Do.                   
                          Maleate Injection,                            
                          U.S.P., 10 mg/mL.                             
83-948.................  Vitamin A Palmitate      Banner Pharmacaps,    
                          Capsules, EQ 50,000      Inc.                 
                          Units Base.                                   
83-973.................  Vitamin A Capsules,      Do.                   
                          50,000 U.S.P. Units.                          
85-591.................  Chlorpromazine           Steris Laboratories,  
                          Hydrochloride            Inc.                 
                          Injection, U.S.P., 25                         
                          mg/mL.                                        
86-419.................  Testosterone Injection,  Do.                   
                          U.S.P., 50 mg/mL.                             
86-420.................  Testosterone Injection,  Do.                   
                          U.S.P., 25 mg/mL.                             
86-468.................  Procainamide             Parke-Davis, Division 
                          Hydrochloride Extended-  of Warner-Lambert    
                          release Tablets,         Co., 2800 Plymouth   
                          U.S.P., 250 mg.          Rd., Ann Arbor, MI   
                                                   48105.               
86-844.................  Acetic Acid Otic         Procter & Gamble      
                          Solution with            Pharmaceuticals,     
                          Hydrocortisone, 2%/1%.   11370 Reed Hartman   
                                                   Hwy. Cincinnati, OH  
                                                   45241-2422.          
86-845.................  Acetic Acid Otic         Do.                   
                          Solution, U.S.P., 2%.                         
87-274.................  Hydroxyzine              Steris Laboratories,  
                          Hydrochloride            Inc.                 
                          Injection, U.S.P., 25                         
                          mg/mL and 50 mg/mL.                           
88-642.................  Diethylpropion           Lemmon Co., 650       
                          Hydrochloride Tablets,   Cathill Rd.,         
                          U.S.P., 25 mg.           Sellersville, PA     
                                                   18960.               
------------------------------------------------------------------------

    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 ANDA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective June 19, 1995.

    Dated: April 18, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-12295 Filed 5-18-95; 8:45 am]
BILLING CODE 4160-01-F