[Federal Register Volume 59, Number 98 (Monday, May 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12554]


[[Page Unknown]]

[Federal Register: May 23, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0181]

 

Fujisawa USA, Inc., et al.; Withdrawal of Approval of 22 
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 22 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withdrawn.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 22, 1994.
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      
------------------------------------------------------------------------
70-223................  Sulfamethoxazole and      Fujisawa USA, Inc.,   
                         Trimethoprim              Parkway North Center,
                         Concentrate for           Three Parkway North, 
                         Injection, USP, 80        Deerfield, IL 60015- 
                         milligrams (mg)/          2548.                
                         milliliters (mL) and 16                        
                         mg/mL.                                         
70-411................  Vincristine Sulfate       Do.                   
                         Injection, USP, 1 mg/mL.                       
71-270................  Tolazamide Tablets, 250   Interpharm, Inc., 3   
                         mg.                       Fairchild Ave.,      
                                                   Plainview, NY 11803. 
71-271................  Tolazamide Tablets, 500   Do.                   
                         mg.                                            
71-299................  Sulfamethoxazole and      Do.                   
                         Trimethoprim Tablets,                          
                         USP, 400 mg/80 mg.                             
71-300................  Sulfamethoxazole and      Do.                   
                         Trimethoprim Tablets,                          
                         USP, 80 mg/160 mg.                             
71-621................  Cholestyramine Resin      Parke-Davis, 2800     
                         Bars (Caramel).           Plymouth Rd., Ann    
                                                   Arbor, MI 48105.     
71-739................  Cholestyramine Resin      Do.                   
                         Bars (Raspberry).                              
83-147................  Sterile Cortisone         Steris                
                         Acetate Suspension,       Laboratories,Inc.,   
                         USP, 25 mg/mL 50 mg/mL.   P.O. Box 23160,      
                                                   Pheonix, AZ 85063-   
                                                   3160.                
84-356................  Edetate Disodium          Do.                   
                         Injection, USP, 150 mg/                        
                         mL.                                            
85-028................  Hydrocortisone Ointment,  Clay-Park Labs, Inc., 
                         USP, 1%.                  1700 Bathgate Ave.,  
                                                   Bronx, NY 10457.     
85-663................  Hydrocortisone Lotion,    Do.                   
                         USP, 1%.                                       
86-466................  Aminophylline Oral        Fisons Corp., 755     
                         Solution, USP, 105 mg/5   Jefferson Rd., P.O.  
                         mL.                       Box 1710, Rochester, 
                                                   NY 14603-1710.       
87-885................  Potassium Chloride for    Fujisawa USA, Inc.    
                         Injection Concentrate,    Parkway North Center,
                         USP.                      Three Parkway North, 
                                                   Deerfield, IL        
87-912................  Triamcinolone Acetonide   Pharmafair Inc., 110  
                         Cream, USP, 0.1%.         Kennedy Drive,       
                                                   Hauppauge, NY 11788  
87-921................  Triamcinolone Acetonide   Do.                   
                         Cream, USP, 0.025%.                            
87-922................  Triamcinolone Acetonide   Do.                   
                         Cream, USP, 0.5%.                              
88-032................  Sulfacetamide Sodium and  Do.                   
                         Prednisolone Acetate                           
                         Ophthalmic Ointment,                           
                         USP, 0.125%.                                   
88-165................  Prednisolone Sodium       Do.                   
                         Phosphate Ophthalmic                           
                         Solution, USP, 1%.                             
88-385................  Sulfacetamide Sodium      Do.                   
                         Ophthalmic Solution,                           
                         USP, 30%.                                      
88-415................  Prednisolone Sodium       Do.                   
                         Phosphate Ophthalmic                           
                         Solution, USP, 0.125%.                         
89-914................  Hydrocortisone Acetate    Parke-Davis.          
                         Cream, USP, 1%.                                
------------------------------------------------------------------------

    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 22, 1994.

    Dated: May 10, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-12554 Filed 5-20-94; 8:45 am]
BILLING CODE 4160-01-F