[Federal Register Volume 59, Number 107 (Monday, June 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13711]


[[Page Unknown]]

[Federal Register: June 6, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

[Docket No. 94N-0195]

 

Adria Laboratories, et al.; Withdrawal of Approval of 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 15 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withdrawn.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: July 6, 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     
------------------------------------------------------------------------
17-959                Fluorouracil                  Adria Laboratories, 
                       Injection,U.S.P., 50          P.O. Box 16529,    
                       milligrams (mg)/milliliter    Columbus, OH 43216-
                       (mL)                          6529.              
18-419                Furosemide Tablets, U.S.P.,   Warner Chilcott     
                       20 mg, 40 mg, and 80 mg       Laboratories, 201  
                                                     Tabor Rd., Morris  
                                                     Plain, NJ 07950.   
18-420                Furosemide Injection,                  Do.        
                       U.S.P., 10 mg/mL                                 
18-670                Furosemide Injection,         Wyeth-Ayerst        
                       U.S.P., 10 mg/mL              Laboratories, P.O. 
                                                     Box 8299,          
                                                     Philadelphia, PA   
                                                     19101-1245.        
18-690                Indomethacin Capsules,        Chelsea             
                       U.S.P., 25 mg and 50 mg       Laboratories, Inc.,
                                                     896 Orlando Ave.,  
                                                     West Hempstead, NY 
                                                     11552.             
19-106                Hydrocortisone Butyrate       Galderma            
                       Ointment 0.1%                 Laboratories, Inc.,
                                                     3000 Alta Mesa     
                                                     Blvd., suite 300,  
                                                     P.O. Box 331329,   
                                                     Fort Worth, TX     
                                                     76163.             
72-398                Sulfamethoxazole and          Barre-National,     
                       Trimethoprim Oral             Inc., 333 Cassell  
                       Suspension, U.S.P., 200 mg/   Dr., suite 3500,   
                       40 mg per 5 mL                Baltimore, MD      
                                                     21224.             
85-191                Hydrocortisone Cream,         Lemmon Co., 650     
                       U.S.P., 1%                    Cathill Rd.,       
                                                     Sellersville, PA   
                                                     18960.             
85-214                Sterile Hydrocortisone,       Steris Laboratories,
                       Acetate Suspension, U.S.P.,   Inc., 620 North    
                       50 mg/mL                      51st Ave., Phoenix,
                                                     AZ 85043-4705.     
86-001                Theophylline Syrup, 80-2 mg/  Barre-National, Inc.
                       15 mL                                            
87-161                Dipyridamole Tablets,         Chelsea             
                       U.S.P., 75 mg                 Laboratories, Inc. 
88-449                Fluocinolone Acetonide,       Pharmafair, Inc.,   
                       Topical Solution, U.S.P.,     110 Kennedy Dr.,   
                       0.01%                         Hauppauge, NY      
                                                     11788.             
88-475                Glycopyrrolate Injection,     Fujisawa USA, Inc., 
                       U.S.P., 0.2 mg/mL             Parkway North      
                                                     Center, Three      
                                                     Parkway North,     
                                                     Deerfield, IL 60015-
                                                     2548.              
88-606                Acetic Acid 2% and Aluminum   Pharmafair, Inc.    
                       Acetate Otic Solution                            
89-223                Theophylline Elixir, 80 mg/   Barre-National, Inc.
                       15 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 ANDA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective July 6, 1994.

    Dated: May 24, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-13711 Filed 6-3-94; 8:45 am]
BILLING CODE 4160-01-F