[Federal Register Volume 62, Number 6 (Thursday, January 9, 1997)]
[Notices]
[Pages 1337-1338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0003]


Hoffman-LaRoche, Inc., et al.; Withdrawal of Approval of 11 New 
Drug Applications, 1 Abbreviated Antibiotic Application, and 20 
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 11 new drug applications (NDA's), 1 abbreviated antibiotic 
application (AADA), and 20 abbreviated new drug applications (ANDA's). 
The holders of the applications 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of the applications be withdrawn.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: February 10, 1997.

FOR FURTHER INFORMATION CONTACT:  Olivia A. Vieira, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1046.

SUPPLEMENTARY INFORMATION: The holders of the applications 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.

                                                                        
------------------------------------------------------------------------
         Application no.                 Drug              Applicant    
------------------------------------------------------------------------
NDA 6-525.......................  Gantrisin           Hoffman-La Roche, 
                                   (sulfisoxazole)     Inc., 340        
                                   Tablets.            Kingsland St.,   
                                                       Bldg. 719-4,     
                                                       Nutley, NJ 07110.
NDA 12-486......................  Taractan            Do.               
                                   (chlorprothixene)                    
                                   Tablets.                             
NDA 12-772......................  Haldrone            Eli Lilly and Co.,
                                   (paramethasone      Lilly Corporate  
                                   acetate) Tablets.   Center,          
                                                       Indianapolis, IN 
                                                       46285.           

[[Page 1338]]

                                                                        
NDA 12-966......................  Masterone           Hoffman-La Roche, 
                                   (dromostanolone     Inc.             
                                   propionate).                         
NDA 13-071......................  Libritabs           Do.               
                                   (chlordiazepoxide                    
                                   ) Tablets, 5, 10,                    
                                   25 milligrams                        
                                   (mg).                                
NDA 13-664......................  GANTANOL            Do.               
                                   (sulfamethoxazole                    
                                   ) Suspension.                        
NDA 16-109......................  Sinubid             Parke-Davis, 2800 
                                   (acetaminophen,     Plymouth Rd., Ann
                                   phenylpropanolami   Arbor, MI 48105. 
                                   ne HCl, and                          
                                   phenyltoloxamine                     
                                   citrate) Extended                    
                                   Release Tablets.                     
NDA 16-943......................  Halotex             Westwood-Squibb   
                                   (haloprogin) 1%     Pharmaceuticals, 
                                   Solution.           Inc.,100 Forest  
                                                       Ave., Buffalo, NY
                                                       14213-1091.      
NDA 17-914......................  OTIC-TRIDESILON     Bayer Corp., 400  
                                   (desonide-acetic    Morgan Ln., West 
                                   acid) Solution      Haven, CT 06516- 
                                   0.05%.              4175.            
NDA 18-366......................  Chymex              Savage            
                                   (bentiromide)       Laboratories,    
                                   Solution.           Division of      
                                                       Altana, Inc., 60 
                                                       Baylis Rd.,      
                                                       Melville, NY     
                                                       11747.           
NDA 18-470......................  Cibacalcin          Ciba-Geigy Corp., 
                                   (calcitonin-        Summit, NJ 07901.
                                   human, for                           
                                   injection).                          
AADA 62-078.....................  Ampicillin          Sandoz            
                                   Trihydrate (bulk).  Pharmaceuticals, 
                                                       59 Route 10, East
                                                       Hanover, NJ07936-
                                                       1080.            
ANDA 70-120.....................  Propranolol         Schering Corp.,   
                                   Hydrochloride       2000 Galloping   
                                   Tablets, 10 mg.     Hill Rd.,        
                                                       Kenilworth, NJ   
                                                       07033.           
ANDA 70-121.....................  Propranolol         Do.               
                                   Hydrochloride                        
                                   Tablets, 20 mg.                      
ANDA 70-122.....................  Propranolol         Do.               
                                   Hydrochloride                        
                                   Tablets, 40 mg.                      
ANDA 70-123.....................  Propranolol         Do.               
                                   Hydrochloride                        
                                   Tablets, 60 mg.                      
ANDA 70-124.....................  Propranolol         Do.               
                                   Hydrochloride                        
                                   Tablets, 80 mg.                      
ANDA 85-288.....................  Acetaminophen and   KV Pharmaceutical 
                                   Codeine Phosphate   Co., 2503 South  
                                   Tablets USP, 300    Hanley Rd., St.  
                                   mg/30 mg.           Louis, MO 63144- 
                                                       2555.            
ANDA 85-484.....................  Chlorpromazine      Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 50                     
                                   mg.                                  
ANDA 85-748.....................  Chlorpromazine      Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 200                    
                                   mg.                                  
ANDA 85-750.....................  Chlorpromazine      Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 10                     
                                   mg.                                  
ANDA 85-751.....................  Chlorpromazine      Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 25                     
                                   mg.                                  
ANDA 85-752.....................  Chlorpromazine      Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 100                    
                                   mg.                                  
ANDA 87-819.....................  Hydroxyzine         Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 10                     
                                   mg.                                  
ANDA 87-820.....................  Hydroxyzine         Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 25                     
                                   mg.                                  
ANDA 87-821.....................  Hydroxyzine         Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 50                     
                                   mg.                                  
ANDA 87-822.....................  Hydroxyzine         Do.               
                                   Hydrochloride                        
                                   Tablets, USP, 100                    
                                   mg.                                  
ANDA 88-344.....................  Triprolidine        H. R. Cenci       
                                   Hydrochloride       Laboratories,    
                                   Pseudoephedrine     Inc., P.O. Box   
                                   Hydrochloride       12524, Fresno, CA
                                   Syrup, 1.25 mg/30   93778-2524.      
                                   mg per 5                             
                                   milliliters (mL).                    
ANDA 88-814.....................  Promethazine with   Do.               
                                   Codeine Syrup                        
                                   (Promethazine                        
                                   Hydrochloride and                    
                                   Codeine Phosphate                    
                                   Oral Solution,                       
                                   6.25 mg/10 mg/5                      
                                   mL).                                 
ANDA 88-815.....................  Promethazine VC     Do.               
                                   Plain Syrup                          
                                   (Promethazine                        
                                   Hydrochloride and                    
                                   Phenylephrine                        
                                   Hydrochloride                        
                                   Oral Solution,                       
                                   6.25 mg/5 mg/5                       
                                   mL).                                 
ANDA 88-816.....................  Promethazine        Do.               
                                   Hydrochloride,                       
                                   Phenylephrine                        
                                   Hydrochloride,                       
                                   Codeine Phospate                     
                                   Syrup, 6.25 mg/5                     
                                   mg/10 mg per 5 mL.                   
ANDA 89-018.....................  Triprolidine        Do.               
                                   Hydrochloride                        
                                   Pseudoephedrine                      
                                   Hydrochloride and                    
                                   Codeine Phosphate                    
                                   Cough Syrup, 1.25                    
                                   mg/30 mg/10 mg                       
                                   per 5 mL.                            
------------------------------------------------------------------------

    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 applications listed in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
February 10, 1997.

    Dated: December 30, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-524 Filed 1-8-97; 8:45 am]
BILLING CODE 4160-01-F