[Federal Register Volume 60, Number 80 (Wednesday, April 26, 1995)]
[Notices]
[Pages 20499-20501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10272]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0101]


Warren Teed Pharmaceuticals, Inc., et al.; Withdrawal of Approval 
of 107 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 107 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withdrawn.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 26, 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      
------------------------------------------------------------------------
83-076.................  Sulfasalazine, 500       Warren Teed           
                          milligrams (mg).         Pharmaceuticals,     
                                                   Inc., Columbus, OH   
                                                   43215.               
83-078.................  Chlorpheniramine         Anabolic, Inc., P.O.  
                          Maleate Tablets, 4 mg.   Box C-19508, Irvine, 
                                                   CA 92713.            
83-135.................  Lidocaine Hydrochloride  G. D. Searle and Co., 
                          Injection, U.S.P., 1%    P.O. Box 5110,       
                          and 2%.                  Chicago, IL 60680.   
83-168.................  Hydrocortisone Liquid,   Dermik Laboratories,  
                          1% and 2 1/2%.           Inc., 500 Arcola Rd.,
                                                   P.O. Box 1200,       
                                                   Collegeville, PA     
                                                   19426-0107.          
83-169.................  Hydrocortisone Gel, 1%   Do.                   
                          and 2 1/2%.                                   
83-184.................  Propoxyphene             Smith, Kline & French,
                          Hydrochloride            One Franklin Plaza,  
                          Capsules, 65 mg.         P.O. Box 7929,       
                                                   Philadelphia, PA     
                                                   19101.               
83-275.................  Diphenhydramine          Anabolic, Inc.        
                          Hydrochloride                                 
                          Capsules, U.S.P., 50                          
                          mg.                                           
83-301.................  Pentobarbital Sodium     Purepac               
                          Capsules, 100 mg.        Pharmaceutical, Co., 
                                                   200 Elmora Ave.,     
                                                   Elizabeth, NJ 07207. 
83-313.................  Triamcinolone Acetonide  Dermik Laboratories,  
                          Ointments, 0.025%,       Inc.                 
                          0.1%, and 0.5%.                               
83-314.................  Triamcinolone Acetonide  Do.                   
                          Creams, 0.025%, 0.1%,                         
                          and 0.5%.                                     
83-363.................  Metaraminol Bitartrate   Elkins-Sinn, Inc., Two
                          Injection, U.S.P., 10    Esterbrook Lane,     
                          mg/milliliters (mL).     Cherry Hill, NJ 08003-
                                                   4099.                
83-554.................  Hydrochlorothiazide      Smith, Kline & French.
                          Tablets, 50 mg.                               
83-567.................  Diphenhydramine          West-Ward             
                          Hydrochloride            Pharmaceutical Corp.,
                          Capsules, 50 mg.         465 Industrial Way,  
                                                   West, Eatontown, NJ  
                                                   07724.               
83-625.................  Tripelennamine           Warner-Lambert, 201   
                          Hydrochloride Tablets,   Tabor Rd., Morris    
                          U.S.P., 25 mg.           Plains, NJ 07950.    
83-626.................  Tripelennamine            Do.                  
                          Hydrochloride Tablets,                        
                          U.S.P., 50 mg.                                
84-125.................  Dextroamphetamine        Purepac               
                          Sulfate Tablets, 5 mg    Pharmaceutical, Co.  
                          and 10 mg.                                    
84-239.................  Hydrocortisone Tablets,  Warner-Lambert.       
                          10 mg.                                        
84-240.................  Prednisone Tablets, 5    Do.                   
                          mg.                                           
84-242.................  Prednisolone Tablets, 5  Do.                   
                          mg.                                           
84-530.................  Aminophylline Tablets,   The Vale Chemical Co.,
                          200 mg.                  Inc., Allentown, PA  
                                                   18102.               
84-531.................  Aminophylline Tablets,   Do.                   
                          100 mg.                                       
84-601.................  Chlordiazepoxide         Mylan Pharmaceuticals,
                          Hydrochloride            Inc., P.O. Box 4310, 
                          Capsules, 10 mg.         781 Chestnut Ridge   
                                                   Rd., Morgantown, WV  
                                                   26505-4310.          
84-699.................  Aminophylline Tablets,   Purepac               
                          100 mg.                  Pharmaceutical, Co.  
84-739.................  Theophylline Elixir, 80  Roxane Laboratories,  
                          mg/15 mL.                Inc., 1809 Wilson    
                                                   Rd., Columbus, OH    
                                                   43228.               
84-880.................  Hydrochlorothiazide      Mylan Pharmaceuticals,
                          Tablets, 25 mg and 50    Inc.                 
                          mg.                                           
85-112.................  Hydrochlorothiazide      Do.                   
                          Tablets, 50 mg.                               
85-195.................  Meclizine Hydrochloride  Circa Pharmaceuticals,
                          Tablets, 12.5 mg.        15 Grand Park Blvd., 
                                                   Athens, OH 45701.    
85-375.................  Acetaminophen Capsules,  McNeil Pharmaceutical,
                          500 mg Oxycodone         Welsh and Mckeon     
                          Hydrochloride            Rds., Spring House,  
                          Capsules, 4.5 mg         PA 19477-0776.       
                          Oxycodone                                     
                          Terephthalate                                 
                          Capsules, 0.38 mg.                            
85-534.................  Sulfisoxazole Tablets,   Chelsea Laboratories, 
                          500 mg.                  Inc., 896 Orlando    
                                                   Ave., West Hempstead,
                                                   NY 11552.            
85-564.................  Aminophylline Tablets,   Do.                   
                          200 mg.                                       
85-567.................  Aminophylline Tablets,   Do.                   
                          100 mg.                                       
[[Page 20500]]                                                          
                                                                        
85-667.................  Hydrocodone Bitartrate   Knoll Pharmaceutical, 
                          Tablets, 5 mg            30 North Jefferson   
                          Acetaminophen Tablets,   Rd., Whippany, NJ    
                          500 mg.                  07981.               
85-867.................  Secobarbital Sodium      Purepac               
                          Capsules, U.S.P., 100    Pharmaceutical, Co.  
                          mg.                                           
85-892.................  Dextroamphetamine        Phoenix               
                          Sulfate Tablets, 10 mg.  Pharmaceutical, Inc.,
                                                   111 Leuning St.,     
                                                   South Hackensack, NJ 
                                                   07606.               
86-044.................  Isosorbide Dinitrate     Circa Pharmaceuticals.
                          Tablets, 10 mg.                               
86-049.................  Brompheniramine Maleate  Purepac Pharmaceutical
                          Tablets, 4 mg.           Co.                  
86-170.................  Hydrocortisone Cream,1%  Stiefel Laboratories, 
                                                   Inc., 2801 Ponce De  
                                                   Leon Blvd., Coral    
                                                   Gables, FL 33134.    
86-202.................  Procaine Hydrochloride   G. D. Searle and Co.  
                          Injection, 1% and 2%.                         
86-205.................  Ammonium Chloride        Do.                   
                          Injection, 3                                  
                          milliquivalent (meq)/                         
                          mL.                                           
86-219.................  Potassium Chloride       Do.                   
                          Injection, U.S.P., 10                         
                          meq/10 mL, 20 meq/10                          
                          mL, 30 meq/mL, and 40                         
                          meq/10 mL.                                    
86-220.................  Potassium Chloride       G. D. Searle and Co.  
                          Injection.                                    
86-302.................  Isosorbide Dinitrate     Purepac               
                          Tablets, 10 mg.          Pharmaceutical, Co.  
86-304.................  Isosorbide Dinitrate     Do.                   
                          Tablets, 5 mg.                                
86-369.................  Hydrochlorothiazide      Smith, Kline & French.
                          Tablets, 25 mg.                               
86-418.................  Metaraminol Bitartrate   McGaw Inc., P.O. Box  
                          Injection, U.S.P..       19791, Irvine, CA    
                                                   92713-9791.          
86-824.................  Hydrocortisone Lotion,   Pharmaceutical        
                          0.5%.                    Associates, Inc.,    
                                                   P.O. Box 128,        
                                                   Conestee, SC 29636.  
86-858.................  Isosorbide Dinitrate     Lederle Labs, One     
                          Tablets, U.S.P., 5 mg.   Cyanamid Co., Wayne, 
                                                   NJ 07470-8426.       
86-862.................  Isosorbide Dinitrate     Do.                   
                          Tablets, U.S.P., 10 mg.                       
86-981.................  Dipyridamole Tablets,    Circa Pharmaceuticals.
                          Coated, 25 mg.                                
87-085.................  Hydralazine              Mylan Pharmaceuticals,
                          Hydrochloride Tablets,   Inc.                 
                          25 mg                                         
                          Hydrochlorothiazide                           
                          Tablets, 15 mg                                
                          Reserpine Tablets, 0.1                        
                          mg.                                           
87-163.................  Isosorbide Dinitrate     D. M. Graham          
                          Chewable Tablets, 5 mg.  Laboratories, Inc.,  
                                                   Hobart, NY 13788.    
87-415.................  Isosorbide Dinitrate     Eon Labs              
                          Capsules T.R., 40 mg,    Manufacturing, Inc., 
                          Green & Clear.           227-15 North Conduit 
                                                   Ave., Laurelton, NY  
                                                   11413.               
87-474.................  Isosorbide Dinitrate     Ascot Hospital        
                          Oral Tablets, 5 mg.      Pharmaceuticals,     
                                                   Inc., 8055 North     
                                                   Ridgeway Ave.,       
                                                   Skokie, IL 60076.    
87-475.................  Isosorbide Dinitrate     Do.                   
                          Oral Tablets, 10 mg.                          
87-476.................  Isosorbide Dinitrate     Do.                   
                          Oral Tablets, 20 mg.                          
87-478.................  Isosorbide Dinitrate     Do.                   
                          Sublinqual Tablets, 5                         
                          mg.                                           
87-484.................  Nitroglycerine TD        Do.                   
                          Capsules, 2.5 mg.                             
87-485.................  Nitroglycerine TD        Do.                   
                          Capsules, 6.5 mg.                             
87-486.................  Isosorbide Dinitrate SR  Do.                   
                          Capsules, 40 mg.                              
87-512.................  Chlordiazepoxide         Do.                   
                          Hydrochloride                                 
                          Capsules, 25 mg.                              
87-514.................  Triprolidine             Pharmaceutical        
                          Hydrochloride Syrup,     Associates, Inc.     
                          1.25 mg/5 mL.                                 
87-517.................  Brompheniramine Maleate  Do.                   
                          Elixir, 2 mg/5 mL.                            
87-518.................  Promethazine             Do.                   
                          Hydrochloride Syrup,                          
                          6.25 mg/5 mL.                                 
87-520.................  Chlorpheniramine         Do.                   
                          Maleate Syrup, 2 mg/5                         
                          mL.                                           
87-522.................  Aminophylline Tablets,   Ascot Hospital        
                          100 mg.                  Pharmaceuticals, Inc.
87-523.................  Aminophylline            Do.                   
                          Tablets,200 mg.                               
87-524.................  Chlordiazepoxide         Do.                   
                          Hydrochloride                                 
                          Capsules, 10 mg.                              
87-525.................  Chlordiazepoxide         Do.                   
                          Hydrochloride                                 
                          Capsules, 5 mg.                               
87-539.................  Hydrochlorothiazide      Do.                   
                          Tablets, 25 mg.                               
87-540.................  Hydrochlorothiazide      Do.                   
                          Tablets, 50 mg.                               
87-541.................  Tolbutamide Tablets,     Do.                   
                          500 mg.                                       
87-542.................  Procainamide             Do.                   
                          Hydrochloride                                 
                          Capsules, 250 mg.                             
87-543.................  Procainamide             Do.                   
                          Hydrochloride                                 
                          Capsules, 500 mg.                             
87-621.................  Aminophylline            G. D. Searle and Co.  
                          Injection, 25 mg/mL.                          
87-660.................  Methocarbamol Tablets,   Ascot Hospital        
                          500 mg.                  Pharmaceuticals, Inc.
87-661.................  Methocarbamol            Do.                   
                          Tablets,750 mg.                               
87-662.................  Sulfamethoxazole         Do.                   
                          Tablets, 500 mg.                              
87-663.................  Propantheline Bromide    Do.                   
                          Tablets, 15 mg.                               
87-685.................  Cyproheptadine           Do.                   
                          Hydrochloride Tablets,                        
                          4 mg.                                         
87-686.................  Acetazolamide Tablets,   Do.                   
                          250 mg.                                       
87-687.................  Spironolactone           Do.                   
                          Tablets,25 mg.                                
87-697.................  Procainamide             Do.                   
                          Hydrochloride                                 
                          Capsules, 375 mg.                             
87-698.................  Chlorthalidone Tablets,  Do.                   
                          25 mg.                                        
87-699.................  Chlorthalidone Tablets,  Do.                   
                          50 mg.                                        
87-734.................  Nitroglycerin Oral       Merrell Dow           
                          Transmucosal Long        Pharmaceuticals,     
                          Acting Tablets, 1 mg.    Inc., 2110 East      
                                                   Galbraith Rd., P.O.  
                                                   Box 156300,          
                                                   Cincinnati, OH 45215-
                                                   6300.                
87-778.................  Dimenhydrinate Tablets,  Republic Drug Co.,    
                          50 mg.                   Inc., 175 Great Arrow
                                                   Ave., Buffalo, NY    
                                                   14207.               
87-934.................  Diphenoxylate            Ascot Hospital        
                          Hydrochloride Tablets,   Pharmaceuticals, Inc.
                          2.5 mg Atropine                               
                          Sulfate Tablets, 0.025                        
                          mg.                                           
88-005.................  Isosorbide Dinitrate     Unit Dose             
                          Sublingual Tablets, 5    Laboratories, 1718   
                          mg.                      Northrock Court,     
                                                   Rockford, IL 61103.  
88-006.................  Isosorbide Dinitrate     Do.                   
                          Tablets, Oral, 10 mg.                         
88-025.................  Spironolactone with      Ascot Hospital        
                          Hydrochlorothiazide      Pharmaceuticals, Inc.
                          Tablets, 25 mg/25 mg.                         
[[Page 20501]]                                                          
                                                                        
88-067.................  Orphenadrine Citrate S.  Do.                   
                          R. Tablets, 100 mg.                           
88-117.................  Triprolidine             West-Ward             
                          Hydrochloride Tablets,   Pharmaceutical Corp. 
                          2.5 mg Pseudoephedrine                        
                          Hydrochloride Tablets,                        
                          60 mg.                                        
88-199.................  Folic Acid Tablets, 1    Unit Dose             
                          mg.                      Laboratories.        
88-256.................  Meclizine Hydrochloride  Do.                   
                          Tablets, 12.5 mg.                             
88-257.................  Meclizine Hydrochloride  Do.                   
                          Tablets, 25 mg.                               
88-288.................  Bethanechol Chloride     Ascot Hospital        
                          Tablets, 10 mg.          Pharmaceuticals, Inc.
88-289.................  Bethanechol Chloride     Do.                   
                          Tablets, 25 mg.                               
88-307.................  Thioridazine             Geneva                
                          Hydrochloride Oral       Pharmaceuticals,     
                          Concentrate, 30 mg/      Inc., 2555 West      
                          milliliters (mL).        Midway Blvd.,        
                                                   Broomfield, CO 80038-
                                                   0446.                
88-308.................  Thioridazine             Do.                   
                          Hydrochloride Oral                            
                          Concentrate, 100 mg/mL.                       
88-318.................  Triprolidine             Circa Pharmaceuticals.
                          Hydrochloride Tablets,                        
                          2.5 mg Pseudoephedrine                        
                          Hydrochloride Tablets,                        
                          60 mg.                                        
88-332.................  Thioridazine             Mylan Pharmaceuticals,
                          Hydrochloride Tablets,   Inc.                 
                          10 mg.                                        
88-333.................  Thioridazine             Do.                   
                          Hydrochloride Tablets,                        
                          25 mg.                                        
88-334.................  Thioridazine             Do.                   
                          Hydrochloride Tablets,                        
                          50 mg.                                        
88-335.................  Thioridazine             Do.                   
                          Hydrochloride Tablets,                        
                          100 mg.                                       
88-582.................  Quinidine Gluconate      Ascot Hospital        
                          Sustained Release        Pharmaceuticals, Inc.
                          Tablets, 324 mg.                              
88-646.................  Methocarbamol Tablets,   Roxane Laboratories,  
                          500 mg.                  Inc.                 
89-079.................  Nitroglycerin            Ascot Hospital        
                          Controlled Release       Pharmaceuticals, Inc.
                          Capsules, 9 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 on May 26, 1995.

    Dated: April 10, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-10272 Filed 4-25-95; 8:45 am]
BILLING CODE 4160-01-F