[Federal Register Volume 61, Number 30 (Tuesday, February 13, 1996)]
[Notices]
[Pages 5562-5564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3077]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0029]


Reed & Carnrick Pharmaceuticals, et al.; Withdrawal of Approval 
of 2 New Drug Applications and 67 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 2 new drug applications (NDA's) and 67 abbreviated new drug 
applications (ANDA's). The holders of 

[[Page 5563]]
the applications 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applications be withdrawn.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: March 14, 1996.

FOR FURTHER INFORMATION CONTACT: Lola Batson, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.

SUPPLEMENTARY INFORMATION: The holders of the NDA's and 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.

                                                                        
------------------------------------------------------------------------
         Application no.                Drug--             Applicant    
------------------------------------------------------------------------
6-309--.........................  Kwell Lotion/Kwell  Reed & Carnrick   
                                   Cream.              Pharmaceuticals, 
                                                       257 Cornelison   
                                                       Ave., Jersey     
                                                       City, NJ 07302-  
                                                       3198.            
10-718..........................  Kwell Shampoo.....  Do.               
70-021--........................  Metronidazole       Halsey Drug Co.,  
                                   Tablets, USP, 250   Inc., 1827       
                                   milligrams (mg)---  Pacific St.,     
                                   -.                  Brooklyn, NY     
                                                       11233.           
70-205--........................  Diphenhydramine     Barre-National,   
                                   Hydrochloride       Inc., Johns      
                                   Cough Syrup, 12.5   Hopkins Bayview  
                                   mg/5 milliliters    Research Campus, 
                                   (mL)--.             333 Cassell Dr., 
                                                       suite 3500,      
                                                       Baltimore, MD    
                                                       21224.           
70-593--........................  Metronidazole       Halsey Drug Co.,  
                                   Tablets, USP, 500   Inc.             
                                   mg.                                  
70-635--........................  Indomethacin        Do.               
                                   Capsules, USP, 50                    
                                   mg.                                  
70-782--........................  Indomethacin        Do.               
                                   Capsules, USP, 25                    
                                   mg.                                  
70-906--........................  Metoclopramide      Do.               
                                   Tablets, USP, 10                     
                                   mg.                                  
71-027--........................  Ibuprofen Tablets,  Do.               
                                   USP, 200 mg.                         
71-028--........................  Ibuprofen Tablets,  Do.               
                                   USP, 300 mg.                         
71-029--........................  Ibuprofen Tablets,  Do.               
                                   USP, 400 mg.                         
71-030--........................  Ibuprofen Tablets,  Do.               
                                   USP, 600 mg.                         
71-292--........................  Diphenhydramine     L. Perrigo Co.,117
                                   Hydrochloride       Water St.,       
                                   Syrup, 12.5 mg/5    Allegan, MI      
                                   mL--.               49010.           
71-434--........................  Lorazepam Tablets,  Halsey Drug Co.,  
                                   USP, 0.5 mg.        Inc.             
71-435--........................  Lorazepam Tablets,  Do.---            
                                   USP, 1 mg.                           
71-436--........................  Lorazepam Tablets,  Do.---            
                                   USP, 2 mg.                           
71-753--........................  Methyldopa          Do.---            
                                   Tablets, USP, 500                    
                                   mg.                                  
71-772--........................  Propranolol         Warner Chilcott,  
                                   Hydrochloride and   201 Tabor Rd.,   
                                   Hydrochlorothiazi   Morris Plains, NJ
                                   de-Tablets, USP,    07950.           
                                   80 mg/ 25 mg-----.                   
72-137--........................  Ibuprofen Tablets,  Halsey Drug Co.,  
                                   USP, 800 mg.        Inc.---          
72-646--........................  Diphenhydramine     Silarx            
                                   Hydrochloride       Pharmaceuticals, 
                                   Syrup, 12.5 mg/5    Inc., 19 West    
                                   mL----.             St., P.O. Box    
                                                       449, Spring      
                                                       Valley, NY 10977.
80-015--........................  Propylthiouracil    Halsey Drug Co.,  
                                   Tablets, USP, 50    Inc.             
                                   mg.                                  
80-304--........................  Prednisolone        Do.               
                                   Tablets, USP, 1                      
                                   mg, 2.5 mg, and 5                    
                                   mg.                                  
80-498--........................  Rauwolfia           Do.--- ---        
                                   Serpentina                           
                                   Tablets, USP, 50                     
                                   mg and 100 mg.                       
83-518--........................  Dienestrol Cream,   Marion Merrill    
                                   USP, 0.01%-----.    Dow, Inc., P.O.  
                                                       Box 9627, Kansas 
                                                       City, MO 64134-  
                                                       0627.            
83-538--........................  Propoxyphene        Halsey Drug Co.,  
                                   Hydrochloride       Inc.             
                                   Capsules, USP, 65                    
                                   mg.                                  
83-546--........................  Estradiol Valerate  Steris            
                                   Injection, USP,     Laboratories,    
                                   10 mg/mL---.        Inc., 620 North  
                                                       51st Ave.,       
                                                       Phoenix, AZ 85043-
                                                       4705.            
83-583--........................  Quinidine Sulfate   Halsey Drug Co.,  
                                   Tablets, USP, 200   Inc.             
                                   mg.                                  
83-598--........................  Folic Acid          Do.               
                                   Tablets, USP, 1                      
                                   mg.                                  
83-871--........................  Acetaminophen and   Do.--- ---        
                                   Codeine Phosphate                    
                                   Tablets, USP, 300                    
                                   mg/15 mg.                            
83-872--........................  Acetaminophen and   Do.--- ---        
                                   Codeine Phosphate                    
                                   Tablets, USP, 300                    
                                   mg/30 mg.                            
83-891--........................  Hydrochlorothiazid  Do.---            
                                   e Tablets, USP,                      
                                   50 mg.                               
84-677--........................  Pentobarbital       Do.---            
                                   Sodium Capsules,                     
                                   USP, 100 mg.                         
84-685--........................  Chlordiazepoxide    Do.---            
                                   Hydrochloride                        
                                   Capsules, USP, 25                    
                                   mg.                                  
84-719--........................  Butabarbital        Do.---            
                                   Sodium Tablets,                      
                                   USP, 15 mg and 30                    
                                   mg.                                  
84-723--........................  Butabarbital        Do.---            
                                   Sodium Elixir,                       
                                   USP, 30 mg/5 mL.                     
85-067--........................  Hydrochlorothiazid  Inwood            
                                   e Tablets, USP,     Laboratories,    
                                   25 mg.              Inc., 909 Third  
                                                       Ave., New York,  
                                                       NY 10022-4731.   
85-148--........................  Theophylline        Sandoz            
                                   Sodium Glycinate    Pharmaceuticals  
                                   Tablets, USP, 150   Corp., 59 Route  
                                   mg.                 10, East Hanover,
                                                       NJ 07936-1080.   
85-211--........................  Diphenoxylate       Halsey Drug Co.,  
                                   Hydrochloride and   Inc. --- --- --- 
                                   Atropine Sulfate                     
                                   Tablets, USP, 2.5                    
                                   mg/0.025 mg.                         
85-339--........................  Chlordiazepoxide    Do. ---           
                                   Hydrochloride                        
                                   Capsules, USP, 10                    
                                   mg.                                  
85-340--........................  Chlordiazepoxide    Do.               
                                   Hydrochloride                        
                                   Capsules, USP, 5                     
                                   mg.                                  
85-409--........................  Aminophylline       Vintage           
                                   Tablets, USP, 100   Pharmaceuticals, 
                                   mg.                 Inc., 3241       
                                                       Woodpark Blvd.,  
                                                       Charlotte, NC    
                                                       28206.           
85-410--........................  Aminophylline       Do. ---           
                                   Tablets, USP, 200                    
                                   mg.                                  
85-922--........................  Amitriptyline       Halsey Drug Co.,  
                                   Hydrochloride       Inc. ---         
                                   Tablets, USP, 25                     
                                   mg.                                  
86-194--........................  Erythrityl          Burroughs Wellcome
                                   Tetranitrate        Co., 3030        
                                   Tablets             Cornwallis Rd.,  
                                   (chewable), 10 mg.  P.O. Box 12700,  
                                                       Research Triangle
                                                       Park, NC 27709-  
                                                       2700.            
86-504--........................  Hydrochlorothiazid  Halsey Drug Co.,  
                                   e Tablets, USP,     Inc. ---         
                                   25 mg.                               
86-549--........................  Acetaminophen and   Do.               
                                   Codeine Phosphate                    
                                   Tablets, USP, 300                    
                                   mg/60 mg.                            
86-588--........................  Phenobarbital with  Do.               
                                   Belladonna                           
                                   Alkaloids Tablets.                   

[[Page 5564]]
                                                                        
86-652--........................  Phenobarbital with  Solvay            
                                   Belladonna          Pharmaceuticals, 
                                   Alkaloids Elixir.   901 Sawyer Rd.,  
                                                       Marietta, GA     
                                                       30062.           
86-662--........................  Phenobarbital with  Pharmaceutical    
                                   Belladonna          Associates, P.O. 
                                   Alkaloids Elixir.   Box 128,         
                                                       Conestee, SC     
                                                       29636.           
87-136--........................  Hydrocortisone      Westwood-Squibb   
                                   Cream, USP, 0.5%,   Pharmaceuticals, 
                                   1%, and 2.5%.       100 Forest Ave., 
                                                       Buffalo, NY 14213-
                                                        1091.           
87-200--........................  Aminophylline       Fujisawa USA,     
                                   Injection USP, 25   Inc., 3 Parkway  
                                   mg/mL.              North, 3d Floor, 
                                                       Deerfield, IL    
                                                       60015-2548.      
87-480--........................  Prednisone          Halsey Drug Co.,  
                                   Tablets, USP, 20    Inc. ---         
                                   mg.                                  
87-802--........................  Dipyridamole        Do. ---           
                                   Tablets, USP, 25                     
                                   mg.                                  
87-803--........................  Dipyridamole        Do.---            
                                   Tablets, USP, 75                     
                                   mg.                                  
87-914--........................  Diphenhydramine     Do.---            
                                   Hydrochloride                        
                                   Capsules, USP, 50                    
                                   mg.                                  
88-048--........................  Fluocinolone        Pharmaderm,       
                                   Acetonide Topical   Division of      
                                   Solution, USP,      Altana, Inc., 60 
                                   0.01%--- -.         Baylis Rd.,      
                                                       Melville, NY     
                                                       11747.           
88-192--........................  Triprolidine and    Halsey Drug Co.,  
                                   Pseudoephedrine     Inc.--- --- ---  
                                   Hydrochloride                        
                                   Tablets, USP, 2.5                    
                                   mg/60 mg.                            
88-466--........................  Dipyridamole        Do.---            
                                   Tablets, USP, 50                     
                                   mg.                                  
88-662--........................  Chlorpropamide      Do.---            
                                   Tablets, USP, 250                    
                                   mg.                                  
89-218--........................  Hydralazine         Do.---            
                                   Hydrochloride                        
                                   Tablets, USP, 10                     
                                   mg.                                  
89-321--........................  Chlorpropamide      Do.---            
                                   Tablets, USP, 100                    
                                   mg.                                  
89-366--........................  Hydroxyzine         Do.---            
                                   Hydrochloride                        
                                   Tablets, USP, 10                     
                                   mg.                                  
89-396--........................  Hydroxyzine         Do.---            
                                   Hydrochloride                        
                                   Tablets, USP, 50                     
                                   mg.                                  
89-448--........................  Butalbital,         Do.--- ---        
                                   Aspirin, and                         
                                   Caffeine Tablets,                    
                                   USP, 50 mg/325 mg/                   
                                   40 mg.                               
89-465--........................  Leucovorin Calcium  Burroughs Wellcome
                                   for Injection, 50   Co.              
                                   mg/vial.                             
89-476--........................  Quinidine           Halsey Drug Co.,  
                                   Gluconate           Inc. --- ---     
                                   Extended-Release                     
                                   Tablets, USP, 324                    
                                   mg.                                  
89-738--........................  Chlorthalidone      Mutual            
                                   Tablets, USP, 25    Pharmaceutical   
                                   mg (Peach).         Co., Inc., 1100  
                                                       Orthodox St.,    
                                                       Philadelphia, PA 
                                                       19124-3131.      
89-739--........................  Chlorthalidone      Do.               
                                   Tablets, USP, 50                     
                                   mg (Aqua).                           
89-833--........................  Leucovorin Calcium  Burroughs Wellcome
                                   for Injection, 25   Co.              
                                   mg/vial.                             
------------------------------------------------------------------------


    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 applications listed above, and all amendments and 
supplements thereto, is hereby withdrawn, effective March 14, 1996.

    Dated: January 29, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-3077 Filed 2-12-96; 8:45 am]
BILLING CODE 4160-01-F