[Federal Register Volume 60, Number 51 (Thursday, March 16, 1995)]
[Notices]
[Page 14289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6426]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0063]


Dey Laboratories, et al.; Withdrawal of Approval of 14 
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 14 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withdrawn.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: April 17, 1995.

FOR FURTHER INFORMATION CONTACT: Carolyn C. Harris, 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      
------------------------------------------------------------------------
70-805................  Metaproterenol Sulfate    Dey Laboratories, 2751
                         Inhalation Solution,      Napa Valley Corporate
                         U.S.P., 5%.               Dr., Napa, CA 94558. 
80-086................  Sulfadiazine Tablets,     Purepac               
                         167 milligrams (mg)       Pharmaceutical, Co., 
                         Sulfamerazine Tablets,    200 Elmora Ave.,     
                         167 mg Sulfamethazine     Elizabeth, NJ 07207. 
                         Tablets, 167 mg.                               
80-120................  Isoniazid Tablets, 100    Towne, Paulsen & Co., 
                         mg.                       Inc., 14527 South San
                                                   Pedro St., Gardena,  
                                                   CA 90248.            
80-132................  Isoniazid Tablets,        Purepac               
                         U.S.P..                   Pharmaceutical, Co.  
80-276................  Testosterone Propionate   Elkins-Sinn, Inc., 2  
                         Injection.                Esterbrook Lane,     
                                                   Cherry Hill, NJ 08003-
                                                   4099.                
80-308................  Methyltestosterone        Purepac               
                         Buccal Tablets, 10 mg.    Pharmaceutical, Co.  
80-309................  Methyltestosterone        Do.                   
                         Tablets, 10 mg.                                
80-310................  Methyltestosterone        Do.                   
                         Tablets, 25 mg.                                
80-459................  Hyrocortisone Emulsion    Elder Pharmaceuticals,
                         Cream, 1%.                Inc., ICN Plaza, 3300
                                                   Highland Ave., Costa 
                                                   Mesa, CA 92626.      
80-475................  Methyltestosterone        Purepac               
                         Tablets.                  Pharmaceuticals, Inc.
80-489................  Hydrocortisone Ointment,  Altana Inc., 60 Baylis
                         0.5%.                     Rd., Melville, NY    
                                                   11747.               
80-581................  Pyridoxine Hydrochloride  Elkins-Sinn, Inc.     
                         Injection U.S.P., 100                          
                         mg/milliliter (mL).                            
80-797................  Chlorpheniramine Maleate  Do.                   
                         Injection, 10 mg/mL and                        
                         100 mg/mL.                                     
                  80-9  Propantheline Bromide     Geneva                
                   28.   Tablets, 15 mg.           Pharmaceuticals,     
                                                   Inc., 2555 West      
                                                   Midway Blvd.,        
                                                   Broomfield, CO 80038-
                                                   0446.                
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    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 April 17, 1995.
    Dated: March 2, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-6426 Filed 3-15-95; 8:45 am]
BILLING CODE 4160-01-F