[Federal Register Volume 59, Number 201 (Wednesday, October 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25909]


[[Page Unknown]]

[Federal Register: October 19, 1994]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0369]

 

King Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 27 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withdrawn.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: November 18, 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      
------------------------------------------------------------------------
70-106..................  Metoclopramide          King Pharmaceuticals, 
                           Tablets, U.S.P., 10     Inc., 501 Fifth St., 
                           milligrams (mg).        Bristol, TN 37620.   
70-484..................  Betamethasone Valerate  Pharmafair, Inc., 110 
                           Lotion, U.S.P., 0.1%.   Kennedy Dr.,         
                                                   Hauppauge, NY 11788. 
72-817..................  Albuterol Tablets,      Warner Chilcott       
                           U.S.P., 2 mg.           Laboratories, 201    
                                                   Tabor Rd., Morris    
                                                   Plains, NJ 07950.    
72-818..................  Albuterol Tablets,      Do.                   
                           U.S.P., 4 mg.                                
80-635..................  Diphenhydramine         Roxane Laboratories,  
                           Hydrochloride           Inc., P.O. Box 16532,
                           Capsules, U.S.P., 50    Colombus, OH 43216-  
                           mg.                     6532.                
80-731..................  Cortisone Acetate       Inwood Laboratories,  
                           Tablets, U.S.P., 25     Inc., 300 Prospect   
                           mg.                     St., Inwood, NY      
                                                   11896.               
80-732..................  Hydrocortisone          Do.                   
                           Tablets, U.S.P., 20                          
                           mg.                                          
80-932..................  Propylthiouracil        Danbury Pharmacal,    
                           Tablets, U.S.P., 50     Inc., 131 West St.,  
                           mg.                     Danbury, CT 06810.   
85-902..................  Homatropine             Lemmon Co., 650       
                           Methylbromide           Cathill Rd.,         
                           Tablets, U.S.P., 10     Sellersville, PA     
                           mg.                     18960.               
86-610..................  Amitriptyline           Do.                   
                           Hydrochloride                                
                           Tablets, U.S.P., 10                          
                           mg.                                          
86-853..................  Amitriptyline           Do.                   
                           Hydrochloride                                
                           Tablets, U.S.P., 150                         
                           mg.                                          
86-854..................  Amitriptyline           Do.                   
                           Hydrochloride                                
                           Tablets, U.S.P., 100                         
                           mg.                                          
86-857..................  Amitriptyline           Do.                   
                           Hydrochloride                                
                           Tablets, U.S.P., 50                          
                           mg.                                          
86-859..................  Amitriptyline           Do.                   
                           Hydrochloride                                
                           Tablets, U.S.P., 25                          
                           mg.                                          
86-860..................  Amitriptyline           Do.                   
                           Hydrochloride                                
                           Tablets, U.S.P., 75                          
                           mg.                                          
87-838..................  Hydrocortisone Cream,   Pharmafair, Inc.      
                           U.S.P., 1%.                                  
88-150..................  Cyclopentolate          Do.                   
                           Hydrochloride                                
                           Ophthalmic Solution,                         
                           U.S.P., 1%.                                  
88-274..................  Tropicamide Ophthalmic  Do.                   
                           Solution, U.S.P.,                            
                           0.5%.                                        
88-433..................  Dexamethasone Sodium    Do.                   
                           Phosphate Ophthalmic,                        
                           Solution, U.S.P.,                            
                           0.1%.                                        
88-560..................  Hydralazine             Amide Pharmaceutical, 
                           Hydrochloride           Inc., 101 East Main  
                           Tablets, U.S.P..        St., Little Falls, NJ
                                                   07424.               
88-643..................  Cyclopentolate          Pharmafair, Inc.      
                           Hydrochloride                                
                           Ophthalmic Solution,                         
                           U.S.P., 0.5%.                                
88-649..................  Hydralazine             Amide Pharmaceutical, 
                           Hydrochloride           Inc.                 
                           Tablets, U.S.P..                             
88-713..................  Hydroxyzine Pamoate     Lemmon Co.            
                           Capsules, U.S.P., 25                         
                           mg.                                          
88-746..................  Theophylline Syrup,     Marion Merrell Dow,   
                           150 mg/15 milliliters.  Inc., P.O. Box 9627, 
                                                   Kansas City, MO 64134-
                                                   0627.                
88-947..................  Sulfacetamide Sodium    Pharmafair, Inc.      
                           10% with                                     
                           Hydroxyethylcellulose                        
                           Ophthalmic Solution.                         
89-115..................  Butalbital,             Krebs and Associates, 
                           Acetaminophen, and      P.C., For U.S.       
                           Caffeine Capsules,      Pharmaceutical Corp.,
                           U.S.P., 50 mg/325 mg/   2401-C Mellon Ct.,   
                           40 mg.                  Decatur, GA 30035.   
89-360..................  Hydrocodone Bitartrate  Central               
                           and Acetaminophen       Pharmaceuticals,     
                           Capsules, U.S.P., 5     Inc., 120 East Third 
                           mg/500 mg.              St., P.O. Box 328,   
                                                   Seymour, IN 47274-   
                                                   0328.                
------------------------------------------------------------------------

    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 November 18, 1994.

    Dated: October 4, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 94-25909 Filed 10-18-94; 8:45 am]
BILLING CODE 4160-01-F