[Federal Register Volume 59, Number 132 (Tuesday, July 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16735]


[[Page Unknown]]

[Federal Register: July 12, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0249]

 

Sandoz Pharmaceuticals Corp., et al.; Withdrawal of Approval of 7 
Abbreviated Antibiotic Applications and 11 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 7 abbreviated antibiotic applications (AADA's) and 11 abbreviated 
new drug applications (ANDA's). The holders of these 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withdrawn.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 11, 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 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, 62-025........  Griseofulvin, U.S.P.      Sandoz Pharmaceuticals  
                       (Nonsterile bulk).        Corp., 59 Rt. 10, East 
                                                 Hanover, NJ 07936-1080.
AADA, 62-323........  Amoxicillin Oral          Apothecon, Inc., P.O.   
                       Suspension, U.S.P., 125   Box 4500, Princeton, NJ
                       milligrams (mg)/5         08543-4500.            
                       milliliters (mL) and                             
                       250 mg/5 mL.                                     
AADA, 62-541........  Nystatin Oral             Pharmafair, Inc., 110   
                       Suspension, U.S.P.,       Kennedy Dr., Hauppauge,
                       100,000 units/mL.         NY 11788.              
AADA, 62-616........  Erythromycin Topical      Do.                     
                       Solution, U.S.P., 2%.                            
AADA, 62-694........  Ampicillin Trihydrate,    Sandoz Pharmaceuticals  
                       U.S.P. (Nonsterile        Corp.                  
                       bulk).                                           
AADA, 62-728........  Amphotericin B for        Fujisawa USA, Inc.,     
                       Injection, U.S.P., 50     Parkway North Center,  
                       mg/vial.                  Three Parkway North,   
                                                 Deerfield, IL 60015-   
                                                 2548.                  
AADA, 63-219........  Amoxicillin Trihydrate,   Sandoz Pharmaceuticals  
                       U.S.P. (Nonsterile        Corp.                  
                       bulk).                                           
ANDA, 71-038........  Lorazepam Tablets,        Warner Chilcott         
                       U.S.P., 1 mg.             Laboratories, 201 Tabor
                                                 Rd., Morris Plains, NJ 
                                                 07950.                 
ANDA, 71-039........  Lorazepam Tablets,        Do.                     
                       U.S.P., 2 mg.                                    
ANDA, 80-431........  Metaraminol Bitartrate    Fujisawa USA, Inc.      
                       Injection, U.S.P., 10                            
                       mg/mL.                                           
ANDA, 80-446........  Reserpine Tablets,        Solvay Pharmaceuticals, 
                       U.S.P., 0.25 mg.          Inc., 901 Sawyer Rd.,  
                                                 Marietta, GA 30062.    
ANDA, 80-563........  Prednisone Tablets,       MK Labs, 11 Fairway     
                       U.S.P., 2.5 mg and 5 mg.  Lane, Trumbull, CT     
                                                 06611.                 
ANDA, 84-035........  Phentermine               Solvay Pharmaceuticals, 
                       Hydrochloride Tablets,    Inc.                   
                       U.S.P., 8 mg.                                    
ANDA, 86-867........  Prednisone Tablets,       Danbury Pharmacal, Inc.,
                       U.S.P., 50 mg.            131 West St., Danbury, 
                                                 CT 06810.              
ANDA, 87-556........  Reserpine, Hydralazine    Do.                     
                       Hydrochloride, and                               
                       Hydrochlorothiazide                              
                       Tablets, U.S.P., 0.1 mg/                         
                       25 mg/15 mg.                                     
ANDA, 87-674........  Phenylbutazone Tablets,   Do.                     
                       U.S.P., 100 mg.                                  
ANDA, 88-087........  Proparacaine              Pharmafair, Inc.        
                       Hydrochloride                                    
                       Ophthalmic Solution,                             
                       U.S.P., 0.5%.                                    
ANDA, 89-572........  Pyridostigmine Bromide    Solvay Pharmaceuticals, 
                       Tablets, U.S.P., 30 mg.   Inc.                   
------------------------------------------------------------------------


    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 11, 1994.

    Dated: June 25, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 94-16735 Filed 7-11-94; 8:45 am]
BILLING CODE 4160-01-P