[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Notices]
[Pages 51457-51458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25198]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0340]


Lilly Research Laboratories, et al.; Withdrawal of Approval of 12 
New Drug Applications, 8 Abbreviated Antibiotic Applications, and 23 
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 12 new drug applications (NDA's), 8 abbreviated antibiotic 
applications (AADA's), and 23 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that the approval of the applications be withdrawn.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: October 2, 1996.

FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1046.

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  6-470......................  Calcium Gluceptate  Lilly Research    
                                                       Laboratories,    
                                                       Lilly Corporate  
                                                       Center,          
                                                       Indianapolis, IN 
                                                       46285.           
NDA  8-826......................  Chlor-Trimeton      Schering Corp.,   
                                   Injection.          2000 Galloping   
                                                       Hill Rd.,        
                                                       Kenilworth, NJ   
                                                       07033.           
NDA  9-585......................  Cort-Dome           Bayer             
                                   (hydrocortisone,    Pharmaceutical,  
                                   cream) Cream, \1/   400 Morgan Ln.,  
                                   2\%, 1%.            West Haven, CT   
                                                       06516-4175.      
NDA  11-284.....................  Meprospan           Wallace           
                                   (meprobamate)       Laboratories,Half
                                   Capsules, 200       Acre Rd., P.O.   
                                   milligrams (mg)     Box 1001,        
                                   and 400 mg.         Cranbury, NJ     
                                                       08512-0181.      
NDA  16-049.....................  Innovar (fentanyl   Janssen           
                                   citrate/            Pharmaceutica,   
                                   droperidol) for     1125 Trenton-    
                                   Injection.          Harbourton Rd.,  
                                                       P.O. Box 200     
                                                       Titusville, NJ   
                                                       08560-0200.      
NDA  17-589.....................  Solatene            Hoffmann-LaRoche  
                                   (betacarotene)      Inc., 340        
                                   Capsules.           Kingsland St.,   
                                                       Nutley, NJ 07110-
                                                       1199.            
NDA  18-669.....................  Niclocide           Bayer             
                                   (niclosamide)       Pharmaceutical.  
                                   Tablets.                             
NDA  18-806.....................  Indomethacin        Warner Chilcott   
                                   Capsules, 25 mg     Laboratories, 200
                                   and 50 mg.          Plymouth Rd., Ann
                                                       Arbor, MI 28105. 
NDA  18-830.....................  Tambocor            3M                
                                   (flecainide         Pharmaceuticals, 
                                   acetate) 50, 100,   3M Center, Bldg. 
                                   150 and 200 mg      270-3A-01, St.   
                                   Tablets.            Paul, MN 55144-  
                                                       1000.            
NDA  19-329.....................  Sodium Chloride     Fujisawa USA,     
                                   Injection 23.4%.    Inc., Parkway    
                                                       North Center,    
                                                       Three Parkway    
                                                       North, Deerfield,
                                                       IL 60015-2548.   
NDA  50-550.....................  Moxan (moxalactam   Lilly Research    
                                   disodium).          Laboratories.    
NDA  50-565.....................  Coatin              Hoffman-LaRoche,  
                                   (amdinocillin).     Inc.             
AADA  60-107....................  Sterile             Lilly Research    
                                   Streptomycin        Laboratories.    
                                   Sulfate.                             

[[Page 51458]]

                                                                        
AADA  60-384....................  Penicillin G        Do.               
                                   Potassium for                        
                                   Injection                            
                                   (buffered).                          
AADA  60-385....................  Neomycin Sulfate    Do.               
                                   Tablets, 500 mg                      
                                   (eq. 350 mg base).                   
AADA  60-403....................  Penicillin G        Do.               
                                   Potassium Tablets.                   
AADA  60-404....................  Streptomycin        Do.               
                                   Sulfate Injection.                   
AADA  60-601....................  Penicillin G        Do.               
                                   Potassium for                        
                                   Injection.                           
AADA  60-687....................  Bacitracin          Do.               
                                   Ophthalmic                           
                                   Ointment, 500                        
                                   units/gram.                          
AADA  61-742....................  Sterile Cefazolin   Fujisawa          
                                   Sodium, vials.      Pharmaceuticals  
                                                       Co., Ltd., 1515  
                                                       Fairway, Rydal   
                                                       Park 181         
                                                       Woodside,Rydal,  
                                                       PA 19046-1664.   
ANDA  70-591....................  Ibuprofen Tablets,  Bayer Corp. 36    
                                   200 mg.             Columbia Rd.,    
                                                       Morristown, NJ   
                                                       07962-1910.      
ANDA  70-626....................  Ibuprofen           Do.               
                                   Capsules, 200 mg.                    
ANDA  71-001....................  Ibuprofen Tablets,  Do.               
                                   200 mg.                              
ANDA  71-002....................  Ibuprofen           Do.               
                                   Capsules, 200 mg.                    
ANDA  71-508....................  Oxazepam Tablets,   Warner Chilcott.  
                                   15 mg.                               
ANDA  71-767....................  Flurazepam          Do.               
                                   Hydrochloride                        
                                   Capsules, 15 mg.                     
ANDA  71-768....................  Flurazepam          Do.               
                                   Hydrochloride                        
                                   Capsules, 30 mg.                     
ANDA  72-138....................  Clonidine           Do.               
                                   Hydrochloride                        
                                   Tablets, 0.1 mg.                     
ANDA  72-139....................  Clonidine           Do.               
                                   Hydrochloride                        
                                   Tablets, 0.2 mg.                     
ANDA  72-140....................  Clonidine           Do.               
                                   Hydrochloride                        
                                   Tablets, 0.3 mg.                     
ANDA  80-419....................  Hydrocortisone      H. R. Cenci       
                                   Acetate Cream, 1%.  Laboratories,    
                                                       Inc., P.O. Box   
                                                       12524, Fresno, CA
                                                       93778-2524.      
ANDA  83-632....................  Isoniazid Tablets,  Halsey Drug Co.,  
                                   50 mg.              Inc., 1827       
                                                       Pacific St.,     
                                                       Brooklyn, NY     
                                                       11233-3599.      
ANDA  85-501....................  Phentermine         Lemmon Co., 650   
                                   Hydrochloride       Cathill Rd.,     
                                   Capsules, 8 mg.     Sellersville, PA 
                                                       18960.           
ANDA  85-502....................  Theophylline        Forest            
                                   Andydrous Oral      Laboratories,    
                                   Suspension, 100     Inc., 909 Third  
                                   mg/5 milliliters    Ave., New York,  
                                   (mL).               NY 10022-4731.   
ANDA  85-924....................  Amitriptyline       Halsey Drug Co.,  
                                   Hydrochloride       Inc.             
                                   Tablets, 150 mg.                     
ANDA  86-240....................  Kenalog-            Apothecon, P.O.   
                                   H         Box 4500,        
                                   (Triamcinolone      Princeton, NJ    
                                   Acetonide) Cream    08543-4500.      
                                   0.1%.                                
ANDA  87-941....................  Diphenhydramine     H. R. Cenci       
                                   Hydrochloride       Laboratories,    
                                   Elixir, 12.5 mg/5   Inc.             
                                   mL.                                  
ANDA  88-303....................  Theophylline        Do.               
                                   Elixir, 80 mg/15                     
                                   mL.                                  
ANDA  88-304....................  Diphenhydramine     Do.               
                                   Hydrochloride                        
                                   Elixir, 12.5 mg/5                    
                                   mL.                                  
ANDA  88-654....................  Theophylline        Central           
                                   Extended-release    Pharmaceuticals, 
                                   Capsules, 125 mg.   Inc., 120 East   
                                                       Third St., P.O.  
                                                       Box 328, Seymour,
                                                       IN 47274-0328.   
ANDA  89-013....................  Promethazine Plain  H. R. Cenci       
                                   Syrup               Laboratories,    
                                   (Promethazine       Inc.             
                                   Hydrochloride),                      
                                   6.25 mg/5 mL.                        
ANDA  89-458....................  Glutethimide        Halsey Drug Co.,  
                                   Tablets,250 mg.     Inc.             
ANDA  89-568....................  Butalbital and      Do.               
                                   Acetaminophen                        
                                   Tablets, 50 mg/                      
                                   325 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 applications listed in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
October 2, 1996.

    Dated: September 10, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-25198 Filed 9-30-96; 8:45 am]
BILLING CODE 4160-01-F