[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Pages 37653-37654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17923]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0207]


Owen/Galderma, et al.; Withdrawal of Approval of 1 New Drug 
Application, 23 Abbreviated New Drug Applications, and 5 Abbreviated 
Antibiotic Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 1 new drug application (NDA), 23 abbreviated new drug applications 
(ANDA's), and 5 abbreviated antibiotic applications (AADA'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of the applications be withdrawn.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: August 21, 1995.

FOR FURTHER INFORMATION CONTACT: Lola 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 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.


                                                                        
------------------------------------------------------------------------
         Appication no.                  Drug              Applicant    
------------------------------------------------------------------------
ANDA 18-795.....................  Hydrocortisone      Owen/Galderma,    
                                   Butyrate Cream,     6201 South       
                                   0.1%.               Freeway, P.O. Box
                                                       6600, Forth      
                                                       Worth, TX 76115. 
NDA 50-610......................  Erythromycin        Paddock           
                                   U.S.P. for          Laboratories,    
                                   Extemporaneous      Inc., P.O. Box   
                                   Compounding of      27286,           
                                   Topical Solutions.  Minneapolis, MN  
                                                       55427.           
AADA 62-656.....................  Nystatin and        Pharmafair, Inc., 
                                   Triamcinolone       8500 Hidden River
                                   Acetonide           Pkwy., Tampa, FL 
                                   Ointment, U.S.P-.   33637.           
AADA 62-657.....................  Nystatin and        Do.               
                                   Triamcinolone                        
                                   Acetonide Cream,                     
                                   U.S.P.                               
AADA 63-183.....................  Cefamandole         Richmar           
                                   Naftate for         International,   
                                   Injection,          Inc., 1706 Birch 
                                   U.S.P., bulk.       Rd., McLean, VA  
                                                       22101.           
AADA 63-184.....................  Sterile             Do.               
                                   Cefamandole                          
                                   Naftate, U.S.P.                      
AADA 64-018.....................  Amikacin Sulfate,   Do.               
                                   U.S.P.,                              
                                   nonsterile bulk.                     
ANDA 70-077.....................  Nitroglycerin       Fujisawa USA,     
                                   Injection,          Inc., 3 Parkway  
                                   U.S.P., 5           North, 3rd floor,
                                   milligrams (mg)/    Deerfield, IL    
                                   milliliter (mL).    60015-2548.      
ANDA 70-524.....................  Dephenhydramine     The Procter and   
                                   Hydrochloride       Gamble Co.,      
                                   Syrup, 12.5 mg/5    Sharon Woods     
                                   mL.                 Technical Center,
                                                       11450 Grooms Rd.,
                                                       Cincinnati, OH   
                                                       45242-1434.      
ANDA 70-648.....................  Naloxone            Fujisawa USA, Inc.
                                   Hydrochloride                        
                                   Injection,                           
                                   U.S.P., 0.02 mg/                     
                                   mL.                                  
ANDA 70-649.....................  Naloxone            Do.               
                                   Hydrochloride                        
                                   Injection,                           
                                   U.S.P., 0.04 mg/                     
                                   mL.                                  
ANDA 72-191.....................  Clofibrate          Geneva            
                                   Capsules, U.S.P.,   Pharmaceuticals, 
                                   500 mg.             Inc., 2555 West  
                                                       Midway Blvd.,    
                                                       P.O. Box 446,    
                                                       Broomfield, CO   
                                                       80038-0446.      
ANDA 83-951.....................  Acetaminophen and   Burroghs Wellcome 
                                   Codeine Phosphate   Co., 3030        
                                   Tablets, U.S.P.,    Cornwallis Rd.,  
                                   300 mg/30 mg and    P.O. Box 12700,  
                                   300 mg/60 mg.       Research Triangle
                                                       Park, NC 27709-  
                                                       2700.            
ANDA 83-963.....................  Quinidine Sulfate   Vintage           
                                   Tablets, U.S.P.,    Pharmaceuticals, 
                                   200 mg.             Inc., 3241       
                                                       Woodpark Blvd.,  
                                                       Charlotte, NC    
                                                       28206.           
ANDA 84-301.....................  Hydralazine         Lemmon Co., Inc., 
                                   Hydrochloride       650 Cathill Rd., 
                                   Tablets, U.S.P.,    Sellersville, PA 
                                   25 mg.              18960.           
ANDA 84-969.....................  Hydrocortisone      Clay-Park Labs.,  
                                   Ointment, U.S.P.,   1700 Bathgate    
                                   0.5%.               Ave., Bronx, NY  
                                                       10457.           
ANDA 84-970.....................  Hydrocortisone      Do.               
                                   Cream, U.S.P.,                       
                                   0.5%.                                
ANDA 85-026.....................  Hydrocortisone      Do.               
                                   Cream, U.S.P., 1%.                   
ANDA 85-500.....................  Phentermine         Lemmon Co.        
                                   Hydrochloride                        
                                   Tablets, U.S.P.,                     
                                   8 mg.                                
ANDA 85-662.....................  Hydrocortisone      Clay-Park Labs.   
                                   Lotion, U.S.P.,                      
                                   0.5%.                                
ANDA 86-095.....................  Chlorpheniramine    Steris            
                                   Maleate             Laboratories,    
                                   Injection,          Inc., P.O. Box   
                                   U.S.P., 100 mg/mL.  23160, Phoenix,  
                                                       AZ 85063-3160.   
ANDA 86-606.....................  Aminophylline       King              
                                   Injection,          Pharmaceuticals, 
                                   U.S.P., 25 mg/mL.   Inc., 501 Fifth  
                                                       St., Bristol, TN 
                                                       37620.           
ANDA 88-123.....................  Isosorbide          Zeneca            
                                   Dinitrate           Pharmaceuticals, 
                                   Tablets, U.S.P.,    1800 Concord     
                                   10 mg, sublingual.  Pike, P.O. Box   
                                                       15437,           
                                                       Wilmington, DE   
                                                       19850-5437.      
ANDA 88-407.....................  Aminophylline       Fujisawa USA, Inc.
                                   Injection,                           
                                   U.S.P., 25 mg/mL,                    
                                   100 mL vials.                        
ANDA 88-448.....................  Dexamethasone       Do.               
                                   Sodium Phosphate                     
                                   Injection,                           
                                   U.S.P., 4 mg/mL,                     
                                   vials.                               
ANDA 88-645.....................  Dicyclomine         Lemmon Co.        
                                   Hydrochloride                        
                                   Capsules, U.S.P.,                    
                                   20 mg.                               

[[Page 37654]]
                                                                        
ANDA 89-222.....................  Hydralazine         Halsey Drug Co.,  
                                   Hydrochloride       Inc., 1827       
                                   Tablets, U.S.P.,    Pacific St.,     
                                   50 mg.              Brooklyn, NY     
                                                       11233.           
ANDA 89-252.....................  Isoetharine         Dey Laboratories, 
                                   Hydrochloride       2751 Napa Valley 
                                   Inhalation          Corporate Dr.,   
                                   Solution, U.S.P.,   Napa, CA 94558.  
                                   1%.                                  
ANDA 89-554.....................  Hydrocodone         Halsey Drug Co.,  
                                   Bitartrate and      Inc.             
                                   Acetaminophen                        
                                   Tablets, U.S.P.,                     
                                   5 mg/500 mg.                         
------------------------------------------------------------------------


    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 and supplements thereto, is hereby 
withdrawn, effective August 21, 1995.

    Dated: July 5, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-17923 Filed 7-20-95; 8:45 am]
BILLING CODE 4160-01-F