[Federal Register Volume 59, Number 98 (Monday, May 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12555]


[[Page Unknown]]

[Federal Register: May 23, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0179]

 

Astra USA, Inc., et al.; Withdrawal of Approval of 62 Abbreviated 
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 62 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withdrawn.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: June 22, 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 below 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      
------------------------------------------------------------------------
70-014.................  Furosemide Injection,    Astra USA, Inc., P.O. 
                          U.S.P., 10 milligrams    Box 4500,            
                          (mg)/ milliliter (mL)    Westborough, MA 01581-
                          (Ampules).               4500.                
70-026.................  Nitroglycerin            International         
                          Injection, U.S.P..       Medication Systems,  
                                                   Ltd., 1886 Santa     
                                                   Anita Ave., South El 
                                                   Monte, CA 91733.     
70-087.................  Dopamine Hydrochloride   Astra USA, Inc.       
                          Injection, U.S.P., 40                         
                          mg/mL (Vials).                                
70-089.................  Dopamine Hydrochloride   Do.                   
                          Injection, U.S.P., 80                         
                          mg/mL (Ampules).                              
70-090.................  Dopamine Hydrochloride   Do.                   
                          Injection, U.S.P., 80                         
                          mg/mL (Vials).                                
70-093.................  Dopamine Hydrochloride   Do.                   
                          Injection, U.S.P., 160                        
                          mg/mL (Vials).                                
70-094.................  Dopamine Hydrochloride   Do.                   
                          Injection, U.S.P., 160                        
                          mg/mL (Ampules).                              
70-459.................  Clonidine Hydrochloride  Par Pharmaceutical,   
                          Tablets, U.S.P., 0.3     Inc., One Ram Ridge  
                          mg.                      Rd., Spring Valley,  
                                                   NY 10977.            
70-460.................  Clonidine Hydrochloride  Do.                   
                          Tablets, U.S.P., 0.2                          
                          mg.                                           
70-461.................  Clonidine Hydrochloride  Do.                   
                          Tablets, U.S.P., 0.1                          
                          mg.                                           
70-565.................  Perphenazine and                               
                          Amitriptyline                                 
                          Hydrochloride Tablets,                        
                          U.S.P., 2 mg/10 mg.                           
70-574.................  Perphenazine and         Do.                   
                          Amitriptyline                                 
                          Hydrochloride Tablets,                        
                          U.S.P., 4 mg/50 mg.                           
70-595.................  Perphenazine and         Do.                   
                          Amitriptyline                                 
                          Hydrochloride Tablets,                        
                          U.S.P., 4 mg/25 mg.                           
70-620.................  Perphenazine and         Do.                   
                          Amitriptyline                                 
                          Hydrochloride Tablets,                        
                          U.S.P., 4 mg/10 mg.                           
70-621.................  Perphenazine and         Do.                   
                          Amitriptyline                                 
                          Hydrochloride Tablets,                        
                          U.S.P., 2 mg/25 mg.                           
70-675.................  Lorazepam Tablets,       Do.                   
                          U.S.P., 0.5 mg.                               
70-676.................  Lorazepam Tablets,       Do.                   
                          U.S.P., 1 mg.                                 
70-677.................  Lorazepam Tablets,       Do.                   
                          U.S.P., 2 mg.                                 
71-152.................  Bretylium Tosylate       Astra USA, Inc.       
                          Injection, 50 mg/mL.                          
71-815.................  Sulfamethoxazole and     Shionogi USA, Inc.,   
                          Trimethoprim Tablets,    3848 Carson St.,     
                          U.S.P., 400 mg/80 mg.    suite 206, Torrance, 
                                                   CA 90503.            
71-816.................  Sulfamethoxazole and     Do.                   
                          Trimethoprim Tablets,                         
                          U.S.P., 800 mg/160 mg.                        
72-020.................  Droperidol Injection,    Astra USA, Inc.       
                          U.S.P., 2.5 mg/mL                             
                          (Syringes).                                   
72-028.................  Fentanyl Citrate 0.05    Do.                   
                          mg/mL and Droperidol                          
                          2.5 mg/mL Injection                           
                          (Syringes).                                   
72-071.................  Nalbuphine               Do.                   
                          Hydrochloride                                 
                          Injection, 10 mg/mL                           
                          (Ampules).                                    
72-072.................  Nalbuphine               Do.                   
                          Hydrochloride                                 
                          Injection, 10 mg/mL                           
                          (Syringes).                                   
72-074.................  Nalbuphine               Do.                   
                          Hydrochloride                                 
                          Injection, 20 mg/mL                           
                          (Ampules).                                    
72-075.................  Nalbuphine               Do.                   
                          Hydrochloride                                 
                          Injection, 20 mg/mL                           
                          (Syringes).                                   
72-082.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P.,                            
                          0.02 mg/mL,                                   
                          Preservative Free                             
                          (Vials).                                      
72-083.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P.,                            
                          0.02 mg/mL,                                   
                          Preservative Free                             
                          (Syringes).                                   
72-084.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P.,                            
                          0.02 mg/mL,                                   
                          Preservative Free                             
                          (Ampules).                                    
72-085.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P.,                            
                          0.02 mg/mL (Ampules).                         
72-087.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P., 0.4                        
                          mg/mL, Preservative                           
                          Free (Vials).                                 
72-088.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P., 0.4                        
                          mg/mL, Preservative                           
                          Free (Syringes).                              
72-089.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P., 0.4                        
                          mg/mL (Ampules).                              
72-090.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P., 0.4                        
                          mg/mL, Preservative                           
                          Free (Ampules).                               
72-092.................  Naloxone Hydrochloride   Do.                   
                          Injection, U.S.P., 1                          
                          mg/mL (Syringes).                             
72-093.................  Naloxone Hydrochloride                         
                          Do. Injection, U.S.P.,                        
                          1 mg/mL (Ampules).                            
72-106.................  Propoxyphene Napsylate   Halsey Drug Co., Inc.,
                          and Acetaminophen        1827 Pacific St.,    
                          Tablets, U.S.P., 100     Brooklyn, NY 11233-  
                          mg/650 mg.               3599.                
72-212.................  Pancuronium Bromide      Astra USA, Inc.       
                          Injection, 2 mg/mL                            
                          (Ampules).                                    
72-275.................  Propranolol              Mylan Pharmaceuticals 
                          Hydrochloride Tablets,   Inc., 781 Chestnut   
                          U.S.P., 60 mg.           Ridge Rd., P.O. Box  
                                                   4310, Morgantown, WV 
                                                   26505-4310.          
80-324.................  Prednisolone Tablets,    West-ward             
                          U.S.P., 5 mg.            Pharmaceutical Corp.,
                                                   465 Industrial Way   
                                                   West, Eatontown, NJ  
                                                   07724.               
80-370.................  Chlorpromazine           Wyeth-Ayerst          
                          Hydrochloride            Laboratories, P.O.   
                          Injection, U.S.P..       Box 8299,            
                                                   Philadelphia, PA     
                                                   19101-8299.          
84-328.................  Hydroflumethiazide with  Do.                   
                          Reserpine.                                    
85-121.................  Atropine Sulfate and     Do.                   
                          Meperidine                                    
                          Hydrochloride                                 
                          Injection.                                    
85-641.................  Dexamethasone Sodium     Do.                   
                          Phosphate Injection,                          
                          U.S.P., 4 mg/mL.                              
86-165.................  Cyproheptadine           Chelsea Laboratories, 
                          Hydrochloride Tablets,   Inc., 896 Orlando    
                          U.S.P., 4 mg.            Ave., West Hempstead,
                                                   NY 11552.            
86-332.................  Meperidine               International         
                          Hydrochloride            Medication Systems,  
                          Injection, U.S.P., 10    Ltd.                 
                          mg/mL.                                        
88-585.................  Dicyclomine              Pioneer               
                          Hydrochloride Tablets,   Pharmaceuticals,     
                          U.S.P., 20 mg.           Inc., 209 40th St.,  
                                                   Irvington, NJ 07111. 
88-731.................  Methocarbamol Tablets,   Do.                   
                          U.S.P., 500 mg.                               
88-949.................  Folic Acid Tablets,      Do.                   
                          U.S.P., 1 mg.                                 
89-082.................  Methocarbamol Tablets,   Do.                   
                          U.S.P., 750 mg.                               
89-361.................  Dicyclomine              Do.                   
                          Hydrochloride                                 
                          Capsules, U.S.P., 10                          
                          mg.                                           
89-390.................  Carisoprodol Tablets,    Do.                   
                          U.S.P., 350 mg.                               
89-449.................  Aluminum Hydroxide, 80   Pennex Products Co.,  
                          mg and Magnesium         Inc., Pennex Dr.,    
                          Trisilicate, 20 mg.      Verona, PA 15147.    
89-592.................  Chlorzoxazone Tablets,                         
                          U.S.P., 250 mg Inc.                           
                          Pioneer                                       
                          Pharmaceuticals,.                             
89-781.................  Meperidine               Astra USA, Inc.       
                          Hydrochloride                                 
                          Injection, U.S.P., 25                         
                          mg/mL (Vials).                                
89-782.................  Meperidine               Do.                   
                          Hydrochloride                                 
                          Injection, U.S.P., 50                         
                          mg/mL (Ampules).                              
89-783.................  Meperidine               Do.                   
                          Hydrochloride                                 
                          Injection, U.S.P., 50                         
                          mg/mL (Vials).                                
89-785.................  Meperidine               Do.                   
                          Hydrochloride                                 
                          Injection, U.S.P., 75                         
                          mg/mL (Vials).                                
89-786.................  Meperidine               Do.                   
                          Hydrochloride                                 
                          Injection, U.S.P., 100                        
                          mg/mL (Ampules).                              
89-787.................  Meperidine               Do.                   
                          Hydrochloride                                 
                          Injection, U.S.P., 100                        
                          mg/mL (Vials).                                
89-948.................  Chlorzoxazone Tablets,   Pioneer               
                          U.S.P., 500 mg.          Pharmaceuticals, 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 ANDA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective June 22, 1994.

    Dated: May 10, 1994.
 Murray M. Lumpkin,
 Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-12555 Filed 5-20-94; 8:45 am]
BILLING CODE 4160-01-F