[Federal Register Volume 60, Number 137 (Tuesday, July 18, 1995)]
[Notices]
[Pages 36811-36812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17641]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0206]


Richmar International, Inc., et al.; Withdrawal of Approval of 2 
Abbreviated Antibiotic Applications and 15 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 2 abbreviated antibiotic applications (AADA's) and 15 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withdrawn.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: August 17, 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 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      
------------------------------------------------------------------------
AADA 60-446 -..........  Tetracycline Oral        Richmar International,
                          Suspension, U.S.P.       Inc., 1706 Birch Rd.,
                                                   McLean, VA 22101.    
AADA 62-502--..........  Nystatin Vaginal         Lemmon Co., 650       
                          Tablets, U.S.P.,         Cathill Rd.,         
                          100,000 units-.          Sellersville, PA     
                                                   18960.               
ANDA 70-438---.........  Propranolol              Warner Chilcott, 201  
                          Hydrochloride Tablets,   Tabor Rd., Morris    
                          U.S.P., 10-milligrams    Plains, NJ 07950.    
                          (mg).                                         
ANDA 70-439-...........  Propranolol                  Do.               
                          Hydrochloride Tablets,                        
                          U.S.P., 20 mg.                                
ANDA 70-440---.........  Propranolol                  Do.               
                          Hydrochloride Tablets,                        
                          U.S.P., 40 mg.                                
ANDA 70-441---.........  Propranolol                  Do.               
                          Hydrochloride Tablets,                        
                          U.S.P., 60 mg.                                

[[Page 36812]]
                                                                        
ANDA 70-442---.........  Propranolol                  Do.               
                          Hydrochloride Tablets,                        
                          U.S.P., 80 mg.                                
ANDA 72-289---.........  Sulfamethoxazole and     Barre-National, Inc., 
                          Trimethoprim Oral        333 Cassell Dr.,     
                          Suspension, U.S.P.,      suite 3500,          
                          200 mg/40 mg per 5       Baltimore, MD 21224. 
                          milliliters (mL).                             
ANDA 80-397---.........  Prednisone Tablets,      Lemmon Co.            
                          U.S.P., 5 mg.                                 
ANDA 80-398---.........  Prednisolone Tablets,        Do.               
                          U.S.P.,-5 mg.                                 
ANDA 84-389---.........  Propantheline Bromide        Do.               
                          Tablets, U.S.P., 15 mg.                       
ANDA 86-490---.........  Chlordiazepoxide             Do.               
                          Hydrochloride                                 
                          Capsules, U.S.P., 10                          
                          mg.                                           
ANDA 86-769---.........  Lindane Lotion, U.S.P.,  Stiefel Laboratories, 
                          1%--.                    Inc., Route 145, Oak 
                                                   Hill, NY 12460.      
ANDA 87-126---.........  Phentermine              Lemmon Co.            
                          Hydrochloride                                 
                          Capsules, U.S.P., 30                          
                          mg (Brown/Clear).                             
ANDA 87-777---.........  Phentermine                  Do.               
                          Hydrochloride                                 
                          Capsules, U.S.P., 30                          
                          mg.                                           
ANDA 87-940---.........  Lindane Shampoo,         Stiefel Laboratories, 
                          U.S.P., 1%--.            Inc.                 
ANDA 88-785---.........  Hydroxyzine              Barre-National, Inc.  
                          Hydrochloride Syrup,                          
                          U.S.P., 10 mg/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 above, and all amendments and 
supplements thereto, is hereby withdrawn, effective August 17, 1995.

    Dated: July 5, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-17641 Filed 7-17-95; 8:45 am]
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