[Federal Register Volume 59, Number 62 (Thursday, March 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7633]


[[Page Unknown]]

[Federal Register: March 31, 1994]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0105]

 

Solvay Pharmaceuticals et al.; Withdrawal of Approval of 24 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 24 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withdrawn.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: May 2, 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          
------------------------------------------------------------------------
80-040     Sulfisoxazole Tablets, U.S.P.,  Solvay Pharmaceuticals, 901  
            500 milligrams (mg).            Sawyer Rd., Marietta, GA    
                                            30062.                      
80-402     Folic Acid Tablets, 1 mg......  Do.                          
80-500     Rauwolfia Serpentina Tablets,   Do.                          
            U.S.P., 50 mg.                                              
83-213     Hydrocortisone Acetate 0.5%     Ferndale Laboratories, Inc., 
            and Pramoxine Hydrochloride     780 West Eight Mile Rd.,    
            1% Lotion.                      Ferndale, MI 48220.         
83-450     Sulfasalazine Tablets, U.S.P.,  Solvay Pharmaceuticals.      
            500 mg.                                                     
83-606     Butabarbital Sodium Tablets,    Do.                          
            U.S.P., 16.2 mg.                                            
83-896     Butabarbital Sodium Tablets,    Do.                          
            U.S.P., 97.2 mg.                                            
83-897     Butabarbital Sodium Tablets,    Do.                          
            U.S.P., 48.6 mg.                                            
83-898     Butabarbital Sodium Tablets,    Do.                          
            U.S.P., 32.4 mg.                                            
83-925     Hydrochlorothiazide Tablets,    Do.                          
            50 mg.                                                      
84-436     Dienestrol Vaginal Cream,       Do.                          
            0.01%.                                                      
84-448     Methocarbamol Tablets, U.S.P.,  Do.                          
            500 mg.                                                     
84-449     Methocarbamol Tablets, U.S.P.,  Do.                          
            750 mg.                                                     
84-777     Mepivacaine Hydrochloride       Naska Pharmacal Co., Inc.,   
            Injection, U.S.P., 3%.          Riverview Rd., P.O. Box 898,
                                            Lincolnton, NC 28093.       
85-010     Mepivacaine Hydrochloride and   Do.                          
            Levonordefrin Injection,                                    
            U.S.P..                                                     
85-323     Hydrochlorothiazide Tablets,    Solvay Pharmaceuticals.      
            25 mg.                                                      
86-922     Isosorbide Dinitrate            Par Pharmaceutical, Inc., One
            Sublingual Tablets, U.S.P., 5   Ram Ridge Rd., Spring       
            mg.                             Valley, NY 10977.           
86-924     Isosorbide Dinitrate            Do.                          
            Sublingual Tablets U.S.P.,                                  
            2.5 mg.                                                     
87-045     Aminophylline Oral Solution,    Fisons Corp., Jefferson Rd., 
            U.S.P..                         P.O. Box 1710, Rochester, NY
                                            14603.                      
87-144     Phentermine Hydrochloride       Ferndale Laboratories, Inc.  
            Capsules, U.S.P., 30 mg.                                    
87-609     Hydralazine Hydrochloride 100   Solvay Pharmaceuticals.      
            mg/Hydrochlorothiazide 50 mg                                
            Capsules.                                                   
87-933     Isosorbide Dinitrate            Par Pharmaceutical, Inc.     
            Sublingual Tablets, U.S.P..                                 
88-041     Hydrocortisone Lotion, U.S.P.,  Solvay Pharmaceuticals.      
            1%.                                                         
88-860     Pseudoephedrine Hydrochloride   Private Formulations, Inc.,  
            and Triprolidine                4600 Plainfield Ave.,       
            Hydrochloride Tablets,          Edison, NJ 08818.           
            U.S.P., 2.5 mg/60 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 ANDA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective May 2, 1994.

    Dated: March 14, 1994.
 Roger L. Williams,
 Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-7633 Filed 3-30-94; 8:45 am]
BILLING CODE 4160-01-F