[Federal Register Volume 61, Number 60 (Wednesday, March 27, 1996)]
[Notices]
[Pages 13506-13508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7309]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES--
[Docket No. 96N-0095]


Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of 49 New 
Drug Applications, 9 Abbreviated Antibiotic Applications, and 36 
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 49 new drug applications (NDA's), 9 abbreviated antibiotic 
applications (AADA's), and 36 abbreviated new drug applications 
(ANDA's). The holders of 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that the approval of the applications be withdrawn.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: April 26, 1996.
FOR FURTHER INFORMATION CONTACT: Lola E. 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 applications 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    
------------------------------------------------------------------------
NDA 3-718.......................  Synkayvite Tablets  Hoffman-La Roche, 
                                   and Injection.      Inc., 340        
                                                       Kingsland St.,   
                                                       Nutley, NJ 07110.
NDA 3-977.......................  Theelin...........  Parke-Davis, 2800 
                                                       Plymouth Rd., Ann
                                                       Arbor, MI 48105. 
NDA 6-071.......................  Berocca Injectable  Hoffman La Roche, 
                                                       Inc.             
NDA 6-128.......................  Sopronol Ointment.  Wyeth-Ayerst      
                                                       Laboratories,    
                                                       P.O. Box 8299,   
                                                       Philadelphia, PA 
                                                       19101-8299.      
NDA 6-129.......................  Sopronol Solution.  Do.               
NDA 6-130.......................  Sopronol Powder...  Do.               
NDA 9-102.......................  Antepar Tablets     Burroughs Wellcome
                                   and Syrup.          Co., 3030        
                                                       Cornwallis Rd.,  
                                                       P.O. Box 12700,  
                                                       Research Triangle
                                                       Park, NC 27709-  
                                                       2700.            

[[Page 13507]]
                                                                        
NDA 9-495.......................  Marezine Injection  Do.               
NDA 9-519.......................  Doriden Tablets...  Rhone-Poulenc     
                                                       Rorer            
                                                       Pharmaceuticals, 
                                                       Inc., 500 Arcola 
                                                       Rd., Colegeville,
                                                       PA 19426-0107.   
NDA 9-660.......................  Noludar Tablets...  Hoffman-La Roche, 
                                                       Inc.             
NDA 10-209......................  Meti-Derm Cream...  Schering Corp.,   
                                                       2000 Galloping   
                                                       Hill Rd.,        
                                                       Kenilworth NJ    
                                                       07033.           
NDA 10-773......................  Correctol Tablets.  Schering-Plough   
                                                       HealthCare       
                                                       Products, 110    
                                                       Allen Rd., P.O.  
                                                       Box 276, Liberty 
                                                       Corner, NJ 07938-
                                                       0276.            
NDA 10-878......................  Visine Eye Drops..  Pfizer            
                                                       Pharmaceuticals, 
                                                       235 East 42d St.,
                                                       New York, NY     
                                                       10017.           
NDA 11-160......................  Thorexin Cough      The Purdue        
                                   Medicine.           Frederick Co.,   
                                                       100 Connecticut  
                                                       Ave., Norwalk, CT
                                                       06856.           
NDA 11-296......................  Sunbath Protective  Revlon, Research  
                                   Tanning Cream.      Center, Inc., 121
                                                       Route 27, Edison,
                                                       NJ 08818.        
NDA 11-297......................  Sunbath Protective  Do.               
                                   Tanning Lotion.                      
NDA 11-657......................  Betaprone.........  Forest            
                                                       Pharmaceuticals, 
                                                       Inc., 909 Third  
                                                       Ave., New York NY
                                                       10022-4731.      
NDA 11-844......................  Arthropan Liquid..  The Purdue        
                                                       Frederick Co.    
NDA 13-077......................  Xylocaine           Astra             
                                   Suppositories.      Pharmaceutical   
                                                       Products, Inc.,  
                                                       50 Otis St.,     
                                                       Westborough, MA  
                                                       01581.           
NDA 13-094......................  Clysodrast          Rhone-Poulenc     
                                   Evacuant Enema.     Rorer            
                                                       Pharmaceuticals, 
                                                       Inc.             
NDA 13-319......................  Iothalamate Sodium  Mallinckrodt      
                                   80%.                Medical Inc., 675
                                                       McDonnell Blvd., 
                                                       P.O. Box 5840,   
                                                       St. Louis, MO    
                                                       63134.           
NDA 13-638......................  Indoklon..........  OHMEDA, Inc., 110 
                                                       Allen Rd., P.O.  
                                                       Box 804, Liberty 
                                                       Corner, NJ 07938.
NDA 14-359......................  Meprobamate         Halsey Drug Co.,  
                                   Tablets.            Inc., 245 Old    
                                                       Hook Rd.,        
                                                       Westwood, NJ     
                                                       07675.           
NDA 14-740......................  Menrium Tablets...  Hoffmann-La Roche,
                                                       Inc.             
NDA 16-144......................  Ethamide Tablets..  Allergan, 2525    
                                                       Dupont Dr., P.O. 
                                                       Box 19534, Irvin,
                                                       CA 92713-9534.   
NDA 16-219......................  Lemon Spree         Colgate-Palmolive 
                                   Deodorant Soap.     Co., 909 River   
                                                       Rd., P.O. Box    
                                                       1343, Piscataway,
                                                       NJ 08855-1343.   
NDA 16-264......................  Palmolive Gold      Do.               
                                   Antibacterial                        
                                   Deodorant Soap.                      
NDA 16-278......................  Tackle Medicated    Do.               
                                   Soap.                                
NDA 16-486......................  Antibacterial       Do.               
                                   Deodorant Soap.                      
NDA 16-768......................  Estrovus Tablets..  Parke-Davis.      
NDA 16-942......................  Halotex 1% Cream..  Westwood-Squibb   
                                                       Pharmaceuticals, 
                                                       100 Forest Ave., 
                                                       Buffalo, NY 14213-
                                                       1091.            
NDA 17-129......................  Cholebrine........  Mallinckrodt      
                                                       Medical, Inc.    
NDA 17-486......................  Heparin Injection.  Akorn, Inc., P.O. 
                                                       Box 1220,        
                                                       Decatur, IL      
                                                       62525.           
NDA 18-144......................  Centrax Capsules..  Parke-Davis       
NDA 18-203......................  Liposyn 10%.......  Abbott            
                                                       Laboratories, D- 
                                                       389, Bldg. AP30, 
                                                       200 Abbott Park  
                                                       Rd., Abbott Park,
                                                       IL 60064-3537.   
NDA 18-223......................  Multivitamin        Do.               
                                   Additive for                         
                                   Injection.                           
NDA 18-288......................  Hypnomidate         Janssen Research  
                                   Injection.          Foundation, 1125 
                                                       Trenton-         
                                                       Harbourton Rd.,  
                                                       P.O. Box 200,    
                                                       Titusville, NJ   
                                                       08560.           
NDA 18-440......................  M.V.C. 9 + 3......  Fujusawa USA,     
                                                       Inc., Parkway    
                                                       North Center,    
                                                       Three Parkway    
                                                       North, Deerfield,
                                                       IL 60015-2548.   
NDA 18-550......................  Rimadyl Tablets...  Hoffmann-La Roche 
                                                       Inc.             
NDA 18-555......................  Yutopar Tablets...  Astra USA, Inc.,  
                                                       P.O. Box 4500,   
                                                       Westborough, MA  
                                                       01581-4500.      
NDA 18-614......................  Liposyn 20%.......  Abbott            
                                                       Laboratories.    
NDA 18-962......................  Manganese Chloride  Do.               
                                   Injection.                           
NDA 19-185......................  Oxytocin in 5%      Do.               
                                   Dextrose                             
                                   Injection.                           
NDA 19-228......................  Magnesium Sulfate   Fujisawa USA, Inc.
                                   Injection.                           
NDA 19-271......................  Chromic Chloride    Do.               
                                   Injection.                           
NDA 19-786......................  Lopressor OROS....  Ciba-Geigy Corp., 
                                                       556 Morris Ave., 
                                                       Summit NJ 07901- 
                                                       1398.            
NDA 50-502......................  Siseptin Injection  Schering Corp.    
NDA 50-523......................  Vira-A............  Parke-Davis.      
NDA 50-532......................  Ilotycin Topical    Lilly Research    
                                   Solution.           Laboratories,    
                                                       Lilly Corporate  
                                                       Center,          
                                                       Indianapolis IN  
                                                       46285.           
AADA 60-842.....................  Penicillin V.       Novo Nordisk      
                                   Potassium.          Pharmaceuticals, 
                                                       Inc., 100        
                                                       Overlook Center, 
                                                       suite 200,       
                                                       Princeton, NJ    
                                                       08540-7810.      
AADA 61-864.....................  Cephradine........  Apothecon Inc.,   
                                                       P.O. Box 4500,   
                                                       Princeton, NJ    
                                                       08543-4500.      
AADA 61-976.....................  Cephradine........  Do.               
AADA 62-047.....................  Erythromycin        KV Pharmaceutical 
                                   Ethylsuccinate      Co., 2503 South  
                                   Oral Suspension.    Hanley Rd., St.  
                                                       Louis, MO 63144- 
                                                       2555.            
AADA 62-171.....................  Chloramphenicol     Optopics          
                                   Ophthalmic          Laboratories     
                                   Solution.           Corp., 32 Main   
                                                       St., P.O. Box    
                                                       210, Fairton, NJ 
                                                       08320-0210.      

[[Page 13508]]
                                                                        
AADA 62-413.....................  Gentamicin Sulfate  Abbott            
                                   in 9% Sodium        Laboratories.    
                                   Chloride.                            
AADA 62-586.....................  Erythromycin        Do.               
                                   Lactobionate for                     
                                   Injection.                           
AADA 62-871.....................  Cephalexin          Yoshitomi         
                                   Capsules.           Pharmaceutical   
                                                       Industries, c/o  
                                                       Warner Chilcott  
                                                       Laboratories, 182
                                                       Tabor Rd., Morris
                                                       Plains, NJ 07950.
AADA 62-872.....................  Cephalex Capsules.  Do.               
ANDA 70-118.....................  Diphenhydramine     Morton Grove      
                                   Hydrochloride       Pharmaceutical,  
                                   Cough Syrup.        Inc., 6451 West  
                                                       Main St., Morton 
                                                       Grove, IL 60053. 
ANDA 70-770.....................  Dexbrompheniramine  Geneva            
                                   Maleate and         Pharmaceuticals, 
                                   Pseudoephedrine     Inc., 2555 West  
                                   Sulfate Extended-   Midway Blvd.,    
                                   Release Tablets.    Broomfield, CO   
                                                       80020.           
ANDA 71-368.....................  Propranolol         Interpharm, Inc., 
                                   Hydrochloride       Three Fairchild  
                                   Tablets.            Ave., Plainview, 
                                                       NY 11803.        
ANDA 71-369.....................  Propranolol         Do.               
                                   Hydrochloride                        
                                   Tablets.                             
ANDA 71-370.....................  Propranolol         Do.               
                                   Hydrochloride                        
                                   Tablets.                             
ANDA 71-371.....................  Propranolol         Do.               
                                   Hydrochloride                        
                                   Tablets.                             
ANDA 71-819.....................  Methylodpa and      Novopharm, Ltd., c/
                                   Hydrochlorothiazi   o Granutec, Inc.,
                                   de Tablets.         4409 Airport Dr. 
                                                       NW., Wilson, NC  
                                                       27896.           
ANDA 71-820.....................  Methyldopa and      Do.               
                                   Hydrochlorothiazi                    
                                   de Tablets.                          
ANDA 71-821.....................  Methyldopa and      Do.               
                                   Hydrochlorothiazi                    
                                   de Tablets.                          
ANDA 71-822.....................  Mehyldopa and       Do.               
                                   Hydrochlorothiazi                    
                                   de Tablets.                          
ANDA 74-106.....................  Naproxen Sodium     Hamilton          
                                   Tablets.            Pharmaceuticals, 
                                                       Ltd., c/o Syntex,
                                                       Inc., 3401       
                                                       Hillview Ave.,   
                                                       P.O. Box 10850,  
                                                       Palo Alto, CA    
                                                       94303.           
ANDA 74-110.....................  Naproxen Tablets..  Do.               
ANDA 80-059.....................  Aminosalicylate     Wallace           
                                   and                 Laboratories,    
                                   Aminosalicylic      301B College Road
                                   Acid Tablets, 846   East, Princeton, 
                                   milligrams (mg)/    NJ 08540.        
                                   112 mg.                              
ANDA 80-271.....................  Methyltestosterone  Rosemont          
                                   Sublingual          Pharmaceutical   
                                   Tablets.            Corp., 301 South 
                                                       Cherokee St.,    
                                                       Denver, CO 80223.
ANDA 80-384.....................  Procaine            Fujisawa USA, Inc.
                                   Hydrochloride                        
                                   Injection.                           
ANDA 83-376.....................  Esterified          Hoffmann-La Roche,
                                   Estrogens Tablets.  Inc.             
ANDA 84-215.....................  Esterified          Do.               
                                   Estrogens Tablets.                   
ANDA 84-216.....................  Esterified          Do.               
                                   Estrogens Tablets.                   
ANDA 84-290.....................  Potassium Chloride  Fujisawa USA, Inc.
                                   for Injection                        
                                   Concentrate.                         
ANDA 85-266.....................  Diphenoxylate       MD                
                                   Hydrochloride and   Pharmaceuticals, 
                                   Atropine Sulfate    Inc., 3130 South 
                                   Tablets.            Harbor Blvd.,    
                                                       suite 320, Santa 
                                                       Ana, CA 92704.   
ANDA 85-303.....................  Amithriptyline      Roche Products,   
                                   Hydrochloride       Inc., State Road 
                                   Tablets.            670, Km. 2.7,    
                                                       P.O. Box 452,    
                                                       Manati PR 00674- 
                                                       0452.            
ANDA 86-587.....................  Phenobarbital with  Halsey Drug Co.,  
                                   Belladonna          Inc.             
                                   Alkaloids Elixir.                    
ANDA 87-723.....................  Diatrizoate         Berlex            
                                   Meglumine and       Laboratories,    
                                   Diatrizoate         Inc., 300        
                                   Sodium Injection.   Fairfield Rd.,   
                                                       Wayne NJ 07470-  
                                                       7358.            
ANDA 87-724.....................  Diatrizoate         Do.               
                                   Meglumine and                        
                                   Diatrizoate                          
                                   Sodium Injection.                    
ANDA 87-725.....................  Diatrizoate Sodium  Do.               
                                   Injection.                           
ANDA 87-726.....................  Diatrizoate         Do.               
                                   Meglumine                            
                                   Injection.                           
ANDA 87-728.....................  Diatrizoate         Do.               
                                   Meglumine and                        
                                   Diatrizoate                          
                                   Sodium Solution.                     
ANDA 87-729.....................  Diatrizoate         Do.               
                                   Meglumine                            
                                   Injection.                           
ANDA 87-731.....................  Diatrizoate         Do.               
                                   Meglumine                            
                                   Injection.                           
ANDA 87-739.....................  Diatrizoate         Do.               
                                   Meglumine                            
                                   Injection.                           
ANDA 87-768.....................  Ipodate Sodium      Do.               
                                   Capsules.                            
ANDA 87-787.....................  Potassium Chloride  Fujisawa USA, Inc.
                                   for Injection                        
                                   Concentrate.                         
ANDA 88-739.....................  Promethazine        Halsey Drug Co.,  
                                   Hydrochloride and   Inc.             
                                   Codeine Phosphate                    
                                   Syrup.                               
ANDA 88-868.....................  Promethazine and    Do.               
                                   Phenylephrine                        
                                   Hydrochlorides                       
                                   Syrup.                               
ANDA 88-870.....................  Promethazine and    Do.               
                                   Phenylephrine                        
                                   Hydrochlorides                       
                                   and Codeine                          
                                   Phosphate Syrup.                     
ANDA 88-913.....................  Promethazine        Do.               
                                   Hydrochloride and                    
                                   Dextromethorphan                     
                                   Hydrobromide                         
                                   Syrup.                               
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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 applications listed above, and all amendments and 
supplements thereto, is hereby withdrawn, effective April 26, 1996.

    Dated: March 7, 1996.
Janet Woodcock,
Center for Drug Evaluation and Research.
[FR Doc. 96-7309 Filed 3-26-96; 8:45 am]
BILLING CODE 4160-01-F