[Federal Register Volume 61, Number 151 (Monday, August 5, 1996)]
[Notices]
[Pages 40649-40653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19804]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0257]


Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of 87 New 
Drug Applications, 18 Abbreviated Antibiotic Drug Applications, and 103 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 87 new drug applications (NDA's), 18 abbreviated antibiotic 
applications (AADA's), and 103 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that the approval of the applications be withdrawn.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: September 4, 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 6-54........................  Progstigmin         Hoffmann-La Roche,
                                   (neostigmine        Inc., 340        
                                   bromide solution)   Kingsland St.,   
                                   Opthalmic           Nutley, NJ 07110-
                                   Solution, 5%.       1199.            
NDA 5-319.......................  Pantopaque          Alcon             
                                   (iophendylate)      Laboratories,    
                                   Injection.          Inc., 6201 South 
                                                       Freeway, Fort    
                                                       Worth, TX 76134- 
                                                       2099.            
NDA 6-135.......................  Folic Acid........  Lilly Research    
                                                       Laboratories,    
                                                       Lilly Corporate  
                                                       Center,          
                                                       Indianopolis, IN 
                                                       46285.           
NDA 6-213.......................  Propylthiouracil    Do.               
                                   Tablets.                             
NDA 6-215.......................  Delphicol Tablets   Lederle           
                                   and Solution.       Laboratories,    
                                                       Pearle River, NY 
                                                       10965.           
NDA 6-333.......................  Synophylate         Central           
                                   (theophylline       Pharmaceuticals, 
                                   sodium glycinate)   Inc., 120 East   
                                   Elixir.             Third St.,       
                                                       Seymour, IN      
                                                       47274.           
NDA 6-386.......................  Mol-Iron Liquid...  Schering-Plough   
                                                       Corp., 110 Allen 
                                                       Rd., P.O. Box    
                                                       276, Liberty     
                                                       Corner, NJ 07938-
                                                       0276.            
NDA 6-686.......................  Dramamine Liquid..  Richardson-Vicks, 
                                                       Inc., One Far    
                                                       Mill Crossing,   
                                                       Shelton, CT      
                                                       06484.           
NDA 6-911.......................  Sulfisoxazole       Roche             
                                   Syrup/Pediatric     Pharmaceuticals, 
                                   Suspension.         340 Kingsland    
                                                       St., Nutley, NJ  
                                                       07110-1199.      
NDA 8-082.......................  Propion Gel.......  Wyeth-Ayerst      
                                                       Laboratories,    
                                                       P.O. Box 8299,   
                                                       Philadelphia, PA 
                                                       19101-8299.      
NDA 8-855.......................  Milontin 500        Parke-Davis       
                                   milligram (mg)      Pharmaceutical   
                                   Kapseals.           Research, 2800   
                                                       Plymouth Rd., Ann
                                                       Arbor, MI 48105. 
NDA 8-951.......................  Pagitane HCl        Lilly Research    
                                   Tablets.            Laboratories.    
NDA 9-008.......................  Salpix Contrast     The R. W. Johnson 
                                   Medium.             Pharmaceutical   
                                                       Research         
                                                       Institute, Rt.   
                                                       202, Box 300,    
                                                       Raritan, NJ 08869-
                                                       0602.            
NDA 9-115.......................  Serpasil Tablets    Ciba-Geigy Corp., 
                                   and Elixir.         556 Morris Ave., 
                                                       Summit, NJ 07901.
NDA 9-220.......................  Di-Isopacin.......  Consolidated      
                                                       Midland Corp., 16-
                                                       20 Main St.,     
                                                       Brewster, NY     
                                                       10509.           
NDA 9-268.......................  Choledyl Tablets,   Parke-Davis       
                                   Pediatric Syrup,    Pharmaceutical   
                                   and Elixir,.        Research.        
NDA 9-296.......................  Serpasil            Ciba-Geigy Corp.  
                                   Apresoline.                          
NDA 9-309.......................  Dionosil Oily.....  Glaxo, Inc., Five 
                                                       Moore Dr., P.O.  
                                                       Box 13358,       
                                                       Research Triangle
                                                       Park, NC 27709.  
NDA 9-434.......................  Serpasil            Ciba-Geigy Corp.  
                                   Parenteral                           
                                   Solution.                            
 NDA 9-750......................  Valmid Capsules,    Lilly Research    
                                   500 mg.             Laboratories.    
NDA 10-291......................  Cortril Soluble     Pfizer, Inc., 235 
                                   Parenteral.         East 42d St., New
                                                       York, NY 10017-  
                                                       5755.            
NDA 10-599......................  Tral Filmtab......  Pharmaceutical    
                                                       Products         
                                                       Division, Abbott 
                                                       Laboratories, One
                                                       Abbott Park Rd., 
                                                       Abbott Park, IL  
                                                       60064-3500.      
NDA 10-670......................  ORINASE Tablets...  The Upjohn Co.,   
                                                       700 Portage Rd., 
                                                       Kalamazoo, MI    
                                                       49001-0199.      
NDA 10-710......................  Toleron Tablets     Wallace           
                                   and Suspension.     Laboratories,    
                                                       Cranbury, NJ     
                                                       08512.           
NDA 10-776......................  DELTA-CORTEF Eye    The Upjohn Co.    
                                   Drops, S.S..                         
NDA 10-911......................  BUCLADIN-S Tablets  Zeneca, 1800      
                                                       Concord Pike,    
                                                       Wilmington, DE   
                                                       19897.           

[[Page 40650]]

                                                                        
NDA 11-078......................  Theruhistin Syrup.  Wyeth-Ayerst      
                                                       Laboratories.    
NDA 11-837......................  Alpha Chymar......  Sola/Barnes-Hind, 
                                                       810 Kifer Rd.,   
                                                       Sunnyvale, CA    
                                                       94086-5200.      
NDA 11-878......................  Serpasil Esidrix..  Ciba-Geigy Corp.  
NDA 13-157......................  Anhydron Tablets..  Lilly Research    
                                                       Laboratories.    
NDA 13-621......................  Pertofrane          Rhone-Poulence    
                                   Capsules.           Rorer            
                                                       Pharmaceuticals, 
                                                       Inc., 500 Arcola 
                                                       Rd., P.O. Box    
                                                       1200,            
                                                       Collegeville, PA 
                                                       19426-0107.      
NDA 14-173......................  Proketazine Oral    Wyeth-Ayerst      
                                   Suspension.         Laboratories.    
NDA 15-148......................  Colgate MFP         Colgate-Palmolive 
                                   Flouride            Co., P.O. Box    
                                   Toothpaste.         1343, 909 River  
                                                       Rd., Piscataway, 
                                                       NJ 08855-1343.   
NDA 16-001......................  BENZTHIAZIDE        Solvay            
                                   Tablets, 25 mg      Pharmaceuticals, 
                                   and 50 mg.          901 Sawyer Rd.,  
                                                       Marietta, GA     
                                                       30062.           
NDA 16-144......................  Ethamide Tablets..  Allergan, 2525    
                                                       Dupont Dr., P.O. 
                                                       Box 19534,       
                                                       Irvine, CA 92713-
                                                       9534.            
NDA 16-287......................  Kaon Sugar Coated   Savage            
                                   Tablets.            Laboratories,    
                                                       Division of      
                                                       Altana, Inc., 60 
                                                       Baylis Rd.,      
                                                       Melville, NY     
                                                       11747.           
NDA 16-749......................  Norlestrin 21 1/50  Parke-Davis       
                                   Tablets.            Pharmaceutical   
                                                       Research.        
NDA 16-764......................  Stemex Oral         Hoffman-LaRoche,  
                                   Tablets.            Inc.             
NDA 16-852......................  Norlestrin 21 2.5/  Parke-Davis       
                                   50 Tablets.         Pharmaceutical   
                                                       Research.        
NDA 16-854......................  Norlestrin FE 2.5/  Do.               
                                   50 Tablets.                          
NDA 16-998......................  Uticort Cream.....  Do.               
NDA 17-226......................  SORBITRATE SA       Zeneca.           
                                   Tablets, 40 mg.                      
NDA 17-421......................  Armohex             The Dial Corp.,   
                                   Hexachlorophene     15191 North      
                                   Liquid Soap Ready   Scottsdale Rd.,  
                                   to Use.             Scottsdale, AZ   
                                                       85260.           
NDA 17-508......................  Lidocaine           Fujisawa USA,     
                                   Hydrochloride       Inc., Parkway    
                                   Injection.          North Center,    
                                                       Three Parkway    
                                                       North, Deerfield,
                                                       IL 60015-2548.   
NDA 17-546......................  Nipride Vials.....  Hoffmann-La Roche,
                                                       Inc.             
NDA 17-675......................  Bethanidine         Medco Research,   
                                   Sulfate Tablets.    Inc., P.O. Box   
                                                       13886, Research  
                                                       Triangle Park, NC
                                                       27709.           
NDA 17-701......................  Lidocaine           International     
                                   Hydrochloride       Medication       
                                   Injection.          Systems, Ltd.,   
                                                       1886 Santa Anita 
                                                       Ave., South El   
                                                       Monte, CA 91733. 
NDA 17-780......................  Heparin Sodium      Pharmaceutical    
                                   Injection.          Specialist       
                                                       Associates, 9852 
                                                       Cowden St.,      
                                                       Philadelphia, PA 
                                                       19115.           
NDA 17-927......................  Globin Zinc         Novo Nordisk      
                                   Insulin Injection.  Pharmaceuticals, 
                                                       Inc., 100        
                                                       Overlook Center, 
                                                       suite 200,       
                                                       Princeton, NJ    
                                                       08540-7810.      
NDA 17-928......................  Protamine Zinc      Do.               
                                   Insulin                              
                                   Suspension.                          
NDA 18-370......................  Furosemide          Superharm Corp.,  
                                   Tablets, 20 mg      600 Corporate    
                                   and 40 mg.          Dr., suite 520,  
                                                       Fort Lauderdale, 
                                                       FL 33334.        
NDA 18-382......................  Semilente Purified  Novo Nordisk      
                                   Pork Prompt         Pharmaceuticals, 
                                   Insulin Zinc        Inc.             
                                   Suspension.                          
NDA 18-385......................  Ultralente          Do.               
                                   Purified Beef                        
                                   Extended Insulin                     
                                   Zinc Suspension.                     
NDA 18-456......................  MICATIN Antifungal  Advanced Care     
                                   Spray Powder.       Products, Ortho  
                                                       Pharmaceutical   
                                                       Corp., Raritan,  
                                                       NJ 08869.        
NDA 18-457......................  MICATIN Antifungal  Do.               
                                   Shaker Powder.                       
NDA 18-524......................  Purified Insulin    Bristol-Myers     
                                   Semilente.          Squibb, P.O. Box 
                                                       4500, Princeton, 
                                                       NJ 08543-4500.   
NDA 18-527......................  Purified Insulin    Do.               
                                   Ultralente.                          
NDA 18-539......................  Regular Iletin II.  Lilly Research    
                                                       Laboratories.    
NDA 18-540......................  Lente Iletin II...  Do.               
NDA 18-541......................  NPH Iletin II.....  Do.               
NDA 18-542......................  Protamine, Zinc,    Do.               
                                   and Ilentin --.                      
NDA 18-605......................  Azulfidine Oral     Kabi Pharmacia, c/
                                   Suspension.         o Adria          
                                                       Laboratories,    
                                                       P.O. Box 16529,  
                                                       Columbus, OH     
                                                       43216-6529.      
NDA 18-633......................  Fibocil Pulvules..  Lilly Research    
                                                       Laboratories.    
NDA 18-666......................  Fibocil Injection.  Do.               
NDA 18-747......................  Isoclor Timesule    CIBA, Mack        
                                   Capsules.           Woodbridge II,   
                                                       581 Main St.,    
                                                       Woodbridge, NJ   
                                                       07095.           
NDA 18-777......................  Novolin L.........  Novo Nordisk      
                                                       Pharmaceuticals, 
                                                       Inc.             
NDA 18-778......................  Novolin R.........  Do.               
NDA 18-928......................  Pentuss Controlled  Fisons Corp., P.O.
                                   Release             Box 1710,        
                                   Suspension.         Rochester, NY    
                                                       14603.           
NDA 18-954......................  0.2% Lidocaine      Abbott            
                                   Hydrochloride in    Laboratories.    
                                   5% Dextrose                          
                                   Injection.                           
NDA 19-005......................  Bretylium Tosylate  Do.               
                                   in 5% Dextrose                       
                                   Injection.                           
NDA 19-046......................  Normozide           Schering Corp.,   
                                   Labetalol.          Galloping Hill   
                                                       Rd., Kenilworth, 
                                                       NJ 07033.        
NDA 19-441......................  Novolin 70/30.....  Novo Nordisk      
                                                       Pharmaceuticals, 
                                                       Inc.             
NDA 19-443......................  Sodium Bicardonate  Abbott            
                                   Injection.          Laboratories.    
NDA 19-456......................  Pindac Pulvules...  Leo Pharmaceutical
                                                       Products, Ltd. A/
                                                       S, 55            
                                                       Industriparken,  
                                                       DK-2750 Ballerup 
                                                       Denmark.         
NDA 19-564......................  Aminosyn II with    Abbott            
                                   Electrolytes in     Laboratories.    
                                   Dextrose                             
                                   Injection.                           
NDA 19-565......................  Aminosyn II 5% in   Do.               
                                   25% Dextrose.                        
NDA 19-693......................  Decabid...........  Lilly Research    
                                                       Laboratories.    
NDA 50-003......................  Erythrocin          Abbott            
                                   Stearate-Sulfas     Laboratories.    
                                   Filmtab/                             
                                   Erythromid                           
                                   Filmtab.                             
NDA 50-069......................  TAO Chewable        Pfizer, Inc.      
                                   Tablets.                             
NDA 50-072......................  Penbritin           Wyeth-Ayerst      
                                   Injection.          Laboratories.    

[[Page 40651]]

                                                                        
NDA 50-126......................  Bicillin Oral       Do.               
                                   Suspension.                          
NDA 50-198......................  Erythrocin Ethyl    Abbott            
                                   Succinate-Sulfas    Laboratories.    
                                   Chewable Tablets.                    
NDA 50-301......................  Veracillin          Wyeth-Ayerst      
                                   Injection.          Laboratories.    
NDA 50-371......................  Ilotycin Sulfa....  Lilly Research    
                                                       Laboratories.    
NDA 50-481......................  Velosef for         Apothecon, P.O.   
                                   Injection.          Box 4500,        
                                                       Princeton, NJ    
                                                       08543-4500.      
NDA 50-523......................  Vira-A 200 mg/      Parke-Davis       
                                   milliliter (mL)     Pharmaceutical   
                                   Intravenous         Research.        
                                   Infusion.                            
NDA 50-699......................  SUPRAX Chewable     Lederle           
                                   Tablet.             Laboratories.    
AADA 60-075.....................  Penicillin G        Pfizer, Inc.      
                                   Potassium                            
                                   Tablets, 200,000                     
                                   Units, 250,000                       
                                   Units, 400,000                       
                                   Units, and                           
                                   800,000 Units.                       
AADA 60-097.....................  Bacitracin          Do.               
                                   Ointment, 500                        
                                   Units/Gram.                          
AADA 60-281.....................  Neomycin and        Do.               
                                   Polymyxin B                          
                                   Sulfates and                         
                                   Bacitracin                           
                                   Ophthalmic                           
                                   Ointment.                            
AADA 60-282.....................  Sterile Bacitracin  Do.               
AADA 60-576.....................  Mycolog II Cream..  Apothecon.        
AADA 60-587.....................  Penicillin G        Pfizer, Inc.      
                                   Potassium for                        
                                   Oral Solution.                       
AADA 60-726.....................  Bacitracin          Do.               
                                   Ophthalmic                           
                                   Ointment.                            
AADA 60-728.....................  Neomycin Sulfate    Do.               
                                   and Bacitracin                       
                                   Ointment.                            
AADA 60-877.....................  Gentamicin Sulfate  Shering Corp.     
AADA 61-815.....................  Penicillin V        Pfizer, Inc.      
                                   Potassium for                        
                                   Oral Solution.                       
AADA 61-836.....................  Penicillin V        Do.               
                                   Potassium                            
                                   Tablets, 250 mg.                     
AADA 61-898.....................  Ampicillin and      Apothecon.        
                                   Probenecid for                       
                                   Oral Suspension.                     
AADA 62-049.....................  Ampicillin for      Pfizer, Inc.      
                                   Oral Suspension.                     
AADA 62-050.....................  Ampicillin          Do.               
                                   Capsules.                            
AADA 62-422.....................  Cephalothin Sodium  Baxter Healthcare 
                                   Injection.          Corp., Rt. 120   
                                                       and Wilson Rd.,  
                                                       Round Lake, IL   
                                                       60073-0490.      
AADA 62-494.....................  Doxycycline         Superpharm Corp.  
                                   Hyclate Tablets.                     
AADA 62-540.....................  Tetracycline        Do.               
                                   Hydrochloride                        
                                   Capsules.                            
AADA 62-730.....................  Cephalothin Sodium  Baxter Healthcare 
                                   Injection.          Corp.            
ANDA 70-065.....................  Sulfamethoxazole    Superpharm Corp.  
                                   and Trimethoprim                     
                                   Tablets, 400 mg/                     
                                   80 mg.                               
ANDA 70-066.....................  Sulfamethoxazole    Superpharm Corp.  
                                   and Trimethoprim                     
                                   Tablets, 800 mg/                     
                                   160 mg.                              
ANDA 70-162.....................  Tolazamide          Barr Laboratories,
                                   Tablets, 100 mg.    Inc., Two Quaker 
                                                       Rd., P.O. Box    
                                                       2900, Pomona, NY 
                                                       10970-0519.      
ANDA 70-163.....................  Tolazamide          Do.               
                                   Tablets, 250 mg.                     
ANDA 70-164.....................  Tolazamide          Do.               
                                   Tablets, 500 mg.                     
ANDA 70-709.....................  Ibuprofen Tablets,  Superpharm Corp.  
                                   600 mg.                              
ANDA 70-926.....................  Metoclopramide      Do.               
                                   Hydrochloride                        
                                   Tablets, 10 mg.                      
ANDA 71-245.....................  Lorazepam Tablets,  Do.               
                                   0.5 mg.                              
ANDA 71-246.....................  Lorazepam Tablets,  Do.               
                                   1 mg.                                
ANDA 71-247.....................  Lorazepam Tablets,  Do.               
                                   2 mg.                                
ANDA 71-319.....................  Propoxyphene        Do.               
                                   Napsylate and                        
                                   Acetaminophen                        
                                   Tablets, 100 mg/                     
                                   650 mg.                              
ANDA 71-659.....................  Flurazepam          Do.               
                                   Hydrochloride                        
                                   Capsules, 15 mg.                     
ANDA 71-660.....................  Flurazepam          Do.               
                                   Hydrochloride                        
                                   Capsules, 30 mg.                     
ANDA 71-771.....................  Propranolol         Warner Chilcott   
                                   Hydrochloride and   Laboratories, 182
                                   Hydrochlorothiazi   Tabor Rd., Morris
                                   de Tablets, 40 mg/  Plains, NJ 07950.
                                   25 mg.                               
ANDA 72-809.....................  Meclofenamate       Barr Laboratories,
                                   Sodium Capsules,    Inc.             
                                   100 mg.                              
ANDA 72-848.....................  Meclofenamate       Do.               
                                   Sodium Capsules,                     
                                   50 mg.                               
ANDA 80-457.....................  Reserpine Tablets,  Halsey Drug Co.,  
                                   0.1 mg and 0.25     Inc., 1827       
                                   mg.                 Pacific St.,     
                                                       Brooklyn, NY     
                                                       11233.           
ANDA 80-721.....................  Reserpine Tablets,  Do.               
                                   0.25 mg.                             
ANDA 80-744.....................  Tripelennamine      Do.               
                                   Hydrochloride                        
                                   Tablets, 50 mg.                      
ANDA 80-854.....................  Pyridoxone          Lilly Research    
                                   Hydrochloride       Laboratories.    
                                   Injection.                           
ANDA 80-855.....................  Cyanocobalamin      Do.               
                                   Injection.                           
ANDA 80-884.....................  Ergocalciferol      Do.               
                                   (Vitamin D)                          
                                   Capsules, 1.25 mg.                   
ANDA 83-130.....................  Ammonium Chloride   Abbott            
                                   Injection.          Laboratories.    
ANDA 83-154.....................  Lidocaine and       Do.               
                                   Epinephrine                          
                                   Injection.                           
ANDA 83-370.....................  Dramamine Tablets.  Richardson-Vicks, 
                                                       Inc.             
ANDA 83-393.....................  Quinidine Sulfate   ICN               
                                   Tablets, 200 mg.    Pharmaceuticals, 
                                                       Inc., ICN Plaza, 
                                                       3300 Hyland Ave.,
                                                       Costa Mesa, CA   
                                                       92626.           
ANDA 83-471.....................  Cortisone Acetate   Barr Laboratories,
                                   Tablets, 25 mg.     Inc.             
ANDA 83-644.....................  Phendimetrazine     Do.               
                                   Tartrate Tablets,                    
                                   35 mg (yellow).                      
ANDA 83-684.....................  Phendimetrazine     Do.               
                                   Tartrate Tablets,                    
                                   35 mg (white).                       
ANDA 83-686.....................  Phendimetrazine     Do.               
                                   Tartrate Tablets,                    
                                   35 mg (gray).                        
ANDA 83-687.....................  Phendimetrazine     Do.               
                                   Tartrate Tablets,                    
                                   35 mg (pink).                        
ANDA 83-944.....................  Triamcinolone       Apothecon.        
                                   Acetonide                            
                                   Ointment, 0.5%.                      
ANDA 83-999.....................  Hydrocortisone      Barr Laboratories,
                                   Tablets, 20 mg.     Inc.             
 ANDA 84-031....................  Sulfisoxazole       Do.               
                                   Tablets, 500 mg.                     
ANDA 84-177.....................  Quinidine Sulfate   Do.               
                                   Tablets, 200 mg.                     
ANDA 84-225.....................  Secobarbital        Do.               
                                   Sodium Capsules,                     
                                   100 mg.                              
ANDA 84-230.....................  Meprobamate         Do.               
                                   Tablets, 600 mg.                     

[[Page 40652]]

                                                                        
ANDA 84-267.....................  Triamcinolone       Do.               
                                   Tablets, 4 mg.                       
ANDA 84-268.....................  Triamcinolone       Do.               
                                   Tablets, 8 mg.                       
ANDA 84-286.....................  Triamcinolone       Do.               
                                   Tablets, 2 mg.                       
ANDA 84-318.....................  Triamcinolone       Do.               
                                   Tablets, 2 mg.                       
ANDA 84-319.....................  Triamcinolone       Do.               
                                   Tablets, 4 mg.                       
ANDA 84-320.....................  Triamcinolone       Do.               
                                   Tablets, 8 mg.                       
ANDA 84-426.....................  Prednisolone        Do.               
                                   Tablets, 5 mg.                       
ANDA 84-468.....................  Brompheniramine     Do.               
                                   Maleate Tablets,                     
                                   4 mg.                                
ANDA 84-579.....................  Reserpine and       Do.               
                                   Hydrochlorothiazi                    
                                   de Tablets, 0.125                    
                                   mg/50 mg.                            
ANDA 84-580.....................  Reserpine and       Do.               
                                   Hydrochlorothiazi                    
                                   de Tablets, 0.125                    
                                   mg/25 mg.                            
ANDA 84-721.....................  Lidocaine           Carlisle          
                                   Hydrochloride       Laboratories,    
                                   Injection, 2%.      Inc., 865 Merrick
                                                       Ave., Westbury,  
                                                       NY 11590.        
ANDA 84-731.....................  Theophylline        R. P. Scherer     
                                   Capsules, 100 mg,   North America,   
                                   200 mg, and 250     2725 Scherer Dr.,
                                   mg.                 St. Petersburg,  
                                                       FL 33176-1016.   
ANDA 84-771.....................  Hydrochlorothiazid  Barr Laboratories,
                                   e Tablets, 50 mg    Inc.             
                                   (yellow).                            
ANDA 84-831.....................  Phendimetrazine     Do.               
                                   Tartrate Tablets,                    
                                   35 mg (green-                        
                                   speckled).                           
ANDA 84-834.....................  Phendimetrazine     Do.               
                                   Tartrate Tablets,                    
                                   35 mg (green).                       
ANDA 84-835.....................  Phendimetrazine     Do.               
                                   Tartrate Tablets,                    
                                   35 mg (pink).                        
ANDA 84-944.....................  Lidocaine           Carlisle          
                                   Ointment, 5%        Laboratories,    
                                   (spearmint).        Inc.             
ANDA 84-946.....................  Lidocaine           Do.               
                                   Ointment, 5%                         
                                   (mixed fruit).                       
ANDA 85-038.....................  Quinidine Sulfate   Eli Lilly and Co. 
                                   Tablets, 200 mg.                     
ANDA 85-068.....................  Quinidine Sulfate   Scherer           
                                   Tablets, 200 mg.    Laboratories,    
                                                       Inc., 2301 Ohio  
                                                       Dr., suite 234,  
                                                       Plano, TX 75093. 
ANDA 85-103.....................  Quinidine Sulfate   Eli Lilly and Co. 
                                   Capsules, 200 mg.                    
ANDA 85-291.....................  Acetaminophen and   Geneva            
                                   Codeine Phosphate   Pharmaceuticals, 
                                   Tablets, 300 mg/    Inc., 2555 West  
                                   30 mg.              Midway Blvd.,    
                                                       P.O. Box 446,    
                                                       Broomfield, CO   
                                                       80038-0446.      
ANDA 85-353.....................  Theophylline        Central           
                                   Tablets, 100 mg     Pharmaceuticals, 
                                   and 200 mg.         Inc.             
ANDA 85-928.....................  Hydrocortisone      Abbott            
                                   Sodium Succinate    Laboratories.    
                                   for Injection.                       
ANDA 85-964.....................  Acetaminophen and   Geneva            
                                   Codeine Phosphate   Pharmaceuticals, 
                                   Tablets, 300 mg/    Inc.             
                                   60 mg.                               
ANDA 86-586.....................  Diphenhydramine     Halsey Drug Co.,  
                                   Hydrochloride       Inc.             
                                   Elixir, 12.5 mg/5                    
                                   mL.                                  
ANDA 87-121.....................  Tolbutamide         Barr Laboratories,
                                   Tablets, 500 mg.    Inc.             
ANDA 87-189.....................  Sulfamethoxazole    Do.               
                                   Tablets, 500 mg.                     
ANDA 87-247.....................  Chlorthalidone      Superpharm Corp.  
                                   Tablets, 50 mg.                      
ANDA 87-982.....................  Nitroglycerin       Zenith            
                                   Extended-Release    Laboratories,    
                                   Capsules, 2.5 mg.   Inc., 140 Legrand
                                                       Ave., Northvale, 
                                                       NJ 07647.        
ANDA 87-983.....................  Nitroglycerin       Do.               
                                   Extended-Release                     
                                   Capsules, 6.5 mg.                    
ANDA 88-213.....................  Triprolidine and    Halsey Drug Co.,  
                                   Pseudoephedrine     Inc.             
                                   Hydrochlorides                       
                                   Syrup, 1.25 mg/                      
                                   30 mg per 5 mL.                      
ANDA 88-297.....................  Aminophylline       Barr Laboratories,
                                   Tablets, 100 mg.    Inc.             
ANDA 88-298.....................  Aminophylline       Do.               
                                   Tablets, 200 mg.                     
ANDA 88-416.....................  Dipyridamole        Do.               
                                   Tablets, 25 mg.                      
ANDA 88-417.....................  Dipyridamole        Do.               
                                   Tablets, 50 mg.                      
ANDA 88-418.....................  Dipyridamole        Do.               
                                   Tablets, 75 mg.                      
ANDA 88-503.....................  Theophylline        Forest            
                                   Controlled-         Pharmaceuticals, 
                                   Release Tablets,    Inc., 909 Third  
                                   100 mg.             Ave., New York,  
                                                       NY 10022-4731.   
ANDA 88-504.....................  Theophylline        Do.               
                                   Controlled-                          
                                   Release Tablets,                     
                                   200 mg.                              
ANDA 88-505.....................  Theophylline        Do.               
                                   Controlled-                          
                                   Release Tablets,                     
                                   300 mg.                              
ANDA 88-695.....................  Chlorpropamide      Superpharm Corp.  
                                   Tablets, 250 mg.                     
ANDA 88-735.....................  Triprolidine        Halsey Drug Co.,  
                                   Hydrochloride       Inc.             
                                   Syrup, 1.25 mg/ 5                    
                                   mL.                                  
ANDA 88-794.....................  Hydroxyzine         Superpharm Corp.  
                                   Hydrochloride                        
                                   Tablets, 10 mg.                      
ANDA 88-795.....................  Hydroxyzine         Do.               
                                   Hydrochloride                        
                                   Tablets, 25 mg.                      
ANDA 88-796.....................  Hydroxzine          Do.               
                                   Hydrochloride                        
                                   Tablets, 50 mg.                      
ANDA 88-812.....................  Chlorpropamide      Barr Laboratories,
                                   Tablets, 100 mg     Inc.             
                                   (white).                             
ANDA 88-813.....................  Chlorpropamide      Do.               
                                   Tablets, 250 mg                      
                                   (white).                             
ANDA 88-827.....................  Hydrochlorothiazid  Superpharm Corp.  
                                   e Tablets, 25 mg.                    
ANDA 88-828.....................  Hydrochlorothiazid  Do.               
                                   e Tablets, 50 mg.                    
ANDA 88-829.....................  Hydrochlorothiazid  Do.               
                                   e Tablets, 100 mg.                   
NADA 88-865.....................  Prednisone          Do.               
                                   Tablets, 5 mg.                       
ANDA 88-866.....................  Prednisone          Do.               
                                   Tablets, 10 mg.                      
ANDA 88-867.....................  Prednisone          Do.               
                                   Tablets, 20 mg.                      
ANDA 88-893.....................  Tolbutamide         Do.               
                                   Tablets, 500 mg.                     
ANDA 88-962.....................  Diphenoxylate       Do.               
                                   Hydrochloride and                    
                                   Atropine Sulfate                     
                                   Tablets, 2.5 mg/                     
                                   0.025 mg.                            
ANDA 89-103.....................  Thioridazine        Do.               
                                   Hydrochloride                        
                                   Tablets, 10 mg.                      
ANDA 89-104.....................  Thioridazine        Do.               
                                   Hydrochloride                        
                                   Tablets, 25 mg.                      
ANDA 89-105.....................  Thioridazine        Do.               
                                   Hydrochloride                        
                                   Tablets, 50 mg.                      
ANDA 89-177.....................  Folic Acid          Barr Laboratories,
                                   Tablets, 1 mg.      Inc.             
ANDA 89-179.....................  Diphenhydramine     Halsey Drug Co.,  
                                   Hydrochloride       Inc.             
                                   Syrup, 12.5 mg/ 5                    
                                   mL.                                  

[[Page 40653]]

                                                                        
ANDA 89-184.....................  Acetaminophen and   Superpharm Corp.  
                                   Codeine Phosphate                    
                                   Tablets, 300 mg/                     
                                   30 mg.                               
ANDA 89-185.....................  Acetaminophen and   Do.               
                                   Codeine Phosphate                    
                                   Tablets, 300 mg/                     
                                   60 mg.                               
ANDA 89-199.....................  Cyproheptadine      Halsey Drug Co.,  
                                   Hydrochloride       Inc.             
                                   Syrup, 2 mg/ 5 mL.                   
ANDA 89-362.....................  Lidocaine           Abbott            
                                   Hydrochloride       Laboratories.    
                                   Injection, 20%.                      
ANDA 89-446.....................  Chlorpropamide      Barr Laboratories,
                                   Tablets, 100 mg     Inc.             
                                   (blue).                              
ANDA 89-447.....................  Chlorpropamide      Do.               
                                   Tablets, 250 mg                      
                                   (blue).                              
------------------------------------------------------------------------


    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 September 4, 1996.

    Dated: July 9, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-19804 Filed 8-02-96; 8:45 am]
BILLING CODE 4160-01-F