[Federal Register Volume 62, Number 186 (Thursday, September 25, 1997)]
[Notices]
[Pages 50387-50390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0399]


Helen A. Ballack Co. et al.; Withdrawal of Approval of 61 New 
Drug Applications, 8 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 61 new drug applications (NDA's), 8 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that the approval of the applications be withdrawn.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: September 25, 1997.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

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,

[[Page 50388]]

by their request, waived their opportunity for a hearing.

                                                                                                                
----------------------------------------------------------------------------------------------------------------
    Application No.                         Drug                                      Applicant                 
----------------------------------------------------------------------------------------------------------------
NDA 4-526               Bal-Con Capsules                             Helen A. Ballack Co., 1356 Book Bldg.,     
                                                                      Detroit, MI 48226.                        
NDA 6-203               Nupercaine Heavy Solution (dibucaine         Novartis Pharmaceuticals Corp., 59 Rt. 10, 
                         hydrochloride)                               East Hanover, NJ 07936-1080.              
NDA 6-514               Benylin (diphenhydramine hydrochloride)      Warner-Lambert Co., 170 Tabor Rd., Morris  
                         Cough Syrup 12.5 milligrams (mg)/            Plains, NJ 07950.                         
                         milliliter (mL)                                                                        
NDA 6-550               ORTHOXICOL Cough Syrup                       The Upjohn Co., 7000 Portage Rd.,          
                                                                      Kalamazoo, MI 49001-0199.                 
NDA 6-658               Floropryl (isoflurophate ophthalmic          Merck & Co., Inc., P.O. Box 4, BLA-20, West
                         solution) Ophthalmic Solution                Point, PA 19486.                          
NDA 6-921               CHLOR-TRIMETON (chlorpheniramine maleate)    Schering-Plough Corp., 2000 Galloping Hill 
                         Tablets and Syrup                            Rd., Kenilworth, NJ 07033.                
NDA 7-635               NPH Insulin                                  Merck Sharp & Dohme, Division of Merck &   
                                                                      Co., Inc.                                 
NDA 7-757               Gantrisin (sulfoxazole diolamine ophthalmic  Hoffman-LaRoche, Inc., 340 Kingsland St.,  
                         solution) Ophthalmic Solution                Nutley, NJ 07110-1199.                    
NDA 9-018               Hydrocortone Acetate Ophthalmic Solution     Merck & Co., Inc.                          
                         and Ophthalmic Ointment                                                                
NDA 10-656              Floropryl (isoflurophate ophthalmic          Do.                                        
                         ointment) Ophthalmic Ointment                                                          
NDA 11-185              Reserpine Tablets USP, 0.1 mg and 0.25 mg    Zenith Goldline Pharmaceuticals, Inc., 140 
                                                                      Legrand Ave., Northvale, NJ 07647.        
NDA 11-300              Paraflex (chlorzoxazone tablet) Caplets,     R. W. Johnson Pharmaceutical Research      
                         250 mg                                       Institute, 920 Rt. 202 South, P.O. Box    
                                                                      300, Raritan, NJ 08860-0602.              
NDA 11-521              Rauwolfia Serpentine Tablets USP, 50 mg and  Zenith Goldline Pharmaceuticals, Inc.      
                         100 mg                                                                                 
NDA 11-919              Otrivin (xylometazoline hydrochloride)       Novartis Pharmaceuticals, Corp., 59 Rt. 10,
                                                                      East Hanover, NJ 07936-1080.              
NDA 17-313              Iodohippurate Sodium I-131 Injection         CIS-US, Inc., 10 De Angelo Dr., Bedford, MA
                                                                      01730.                                    
NDA 17-672              Lithonate Syrup (Lithium Citrate Syrup,      Solvay Pharmaceuticals, Inc., 901 Sawyer   
                         USP)                                         Rd., Marietta, GA 30062.                  
NDA 17-792              AN-MAA, Technetium TC 99m Albumin            CIS-US, Inc.                               
                         Aggregated Kit                                                                         
NDA 17-996              Semilente Insulin (prompt insulin zinc       Novo Nordisk Pharmaceuticals, Inc., suite  
                         suspension, USP (Beef))                      200, 100 Overlook Center, Princeton, NJ   
                                                                      08540-7810.                               
NDA 17-997              Ultralente Insulin (extended insulin zinc    Novo Nordisk.                              
                         suspension, USP (Beef))                                                                
NDA 18-125              Halog (halcinonide ointment) Ointment,       Bristol-Myers Squibb Pharmaceutical        
                         0.025%                                       Research Institute, P.O. Box 4000,        
                                                                      Princeton, NJ 08543-4000.                 
NDA 18-055              3.3% Dextrose and 0.3% Sodium Chloride       Abbott Laboratories, D-389 Bldg. AP30, 200 
                         Injection in Flexible Containers             Abbott Park Rd., Abbott Park, IL 60064-   
                                                                      3537.                                     
NDA 18-384              Lentard (Purified pork and beef insulin      Novo Nordisk.                              
                         zinc suspension)                                                                       
NDA 18-462              Ringer's Irrigation in Flexible Containers   Abbott Laboratories.                       
NDA 18-525              Purified beef insulin zinc suspension        Novo Nordisk.                              
NDA 18-526              Isophane purified beef insulin suspension    Do.                                        
NDA 18-528              Purified pork insulin injection              Do.                                        
NDA 18-804              Aminosyn 3.5% and 3.5%M in Flexible          Abbott Laboratories.                       
                         Containers                                                                             
NDA 18-875              Aminosyn 3.5% and 3.5%M in CR3 Flexible      Do.                                        
                         Containers                                                                             
NDA 18-923              38.5% Dextrose Injection in Flexible         Do.                                        
                         Containers                                                                             
NDA 19-065              Novolin N NPH Human Insulin Isophane         Novo Nordisk.                              
                         Suspension (semi-synthetic)                                                            
NDA 19-118              Aminosyn 3.5% and 25% Dextrose Injection     Abbott Laboratories.                       
NDA 19-119              Aminosyn 4.25% and 25% Dextrose Injection    Do.                                        
NDA 19-120              Aminosyn 3.5% and 5% Dextrose Injection      Do.                                        
NDA 19-218              0.9% Sodium Chloride Injection in Plastic    Do.                                        
                         Vials                                                                                  
NDA 19-339              Heparin Sodium in 5% Dextrose Injection in   Do.                                        
                         CR3 Flexible Container                                                                 
NDA 19-400              Aminosyn-HBC 7% in CR3 Flexible Containers   Do.                                        
NDA 19-449              Insulatard NPH Human (human insulin (semi-   Novo Nordisk.                              
                         synthetic) isophane suspension)                                                        
NDA 19-482              5% Dextrose and 0.225% Sodium Chloride       Abbott Laboratories.                       
                         Injection in 250 mL ADD-Vantage Flexible                                               
                         Containers                                                                             
NDA 19-483              5% Dextrose and 0.9% Sodium Chloride         Do.                                        
                         Injection in 250 mL ADD-Vantage Flexible                                               
                         Containers                                                                             
NDA 19-484              5% Dextrose and 0.45% Sodium Chloride        Do.                                        
                         Injection in 250 mL ADD-Vantage Flexible                                               
                         Containers                                                                             
NDA 19-485              Lactated Ringer's Injection in 250 mL ADD-   Do.                                        
                         Vantage Flexible Containers                                                            
NDA 19-486              5% Dextrose and 0.3% Sodium Chloride         Do.                                        
                         Injection in 250 mL ADD-Vantage Flexible                                               
                         Containers                                                                             
NDA 19-491              Aminosyn II 3.5% in CR3 Flexible Containers  Do.                                        
NDA 19-493              Aminosyn II 3.5M in CR3 Flexible Containers  Do.                                        

[[Page 50389]]

                                                                                                                
NDA 19-504              Aminosyn II 4.25% w/25% Dextrose in Dual-    Do.                                        
                         Chamber Flexible Container                                                             
NDA 19-505              Aminosyn II 3.5% w/25% Dextrose in CR3 Dual- Do.                                        
                         Chamber Flexible Container                                                             
NDA 19-506              Aminosyn II 3.5% w/5% Dextrose in CR3 Dual-  Do.                                        
                         Chamber Flexible Container                                                             
NDA 19-712              Aminosyn II w/Electrolytes in Dextrose       Do.                                        
                         Injection in 2000 mL CR3 Flexible                                                      
                         Container                                                                              
NDA 19-713              Aminosyn II in Dextrose Injection in CR3     Do.                                        
                         Flexible Containers                                                                    
NDA 19-714              Aminosyn II w/Electrolytes in Dextrose       Do.                                        
                         Injection w/Calcium in 2000 mL CR3                                                     
                         Flexible Container                                                                     
NDA 19-837              Bretylium Tosylate in 5% Dextrose Injection  Baxter Healthcare Corp., Rt. 120 and Wilson
                         in Plastic Container, PL 146                 Rd., Round Lake, IL 60073-0490.           
NDA 20-043              OMNIFLOX (temafloxacin hydrochloride)        Abbott Laboratories.                       
                         Filmtab Tablets                                                                        
NDA 50-188              VINACTANE (sterile viomycin sulfate)         Novartis Pharms, 556 Morris Ave., Summit,  
                                                                      NJ 07901.                                 
NDA 50-019              Penbritin Drops                              Wyeth-Ayerst Laboratories, P.O. Box 8299,  
                                                                      Philadelphia, PA 19101-8299.              
NDA 50-028              DYNAPEN (Dicloxacillin sodium menohydrate)   Bristol-Myers, U.S. Pharmaceutical Group,  
                         Capsules                                     Evansville, IN 47721-0001.                
NDA 50-029              Hetacillin Potassium, Sterile                Bristol-Myers Squibb Co., P.O. Box 4755,   
                                                                      Syracuse, NY 13221-4755.                  
NDA 50-134              SYNCILLIN (phenethicillin potassium) O.S.    Bristol-Myers, U.S. Pharmaceutical Group.  
NDA 50-328              Methicillin Sodium                           Bristol-Myers Squibb Co.                   
NDA 50-378              Neohydeltrasol (neomycin sulfate/            Merck & Co., Inc.                          
                         prednisolone sodium sulfate ophthalmic                                                 
                         ointment) Ophthalmic Ointment                                                          
NDA 50-562              Azlin (azlocillin sodium)                    Miles, Pharmaceutical Division, 400 Morgan 
                                                                      Lane, West Haven, CT 06516-4175.          
NDA 50-618              AMIKIN (amikacin sulfate) in 0.9% NaCL (PVC  Apothecon, P.O. Box 4500, Princeton, NJ    
                         flexible containers)                         08543-4500.                               
AADA 60-291             Tetracycline Oral Suspension USP, 125 mg/5   Purepac Pharmaceutical Co., 200 Elmora     
                         mL                                           Ave., Elizabeth, NJ 07207.                
AADA 62-218             Ampicillin Trihydrate, bulk drug             ACS Dobfar SpA, U.S. Agent: Interchem      
                                                                      Corp., 120 Rt. 17 North, P.O. Box 1579,   
                                                                      Paramus, NJ 07653-1579.                   
AADA 62-319             Tetracycline Hydrochloride (bulk,            Tianjin Pharmaceuticals Corp., U.S. Agent: 
                         nonsterile)                                  Darsheng Trade & Tech. Dev. Co., Ltd.,    
                                                                      P.O. Box 1220, 655 Amboy Ave., A-wing, 1st
                                                                      Fl., Woodbridge, NJ 07095.                
AADA 62-387             Nystatin Cream USP, 100,000 Units/g          Alpharma, U.S. Pharmaceuticals Div., Johns 
                                                                      Hopkins Bayview Center, 333 Cassell Dr.,  
                                                                      suite 3500, Baltimore, MD 21224.          
AADA 62-571             Nystatin Oral Suspension USP, 100,000 Units/ Do.                                        
                         mL                                                                                     
AADA 62-731             Nystatin Ointment USP, 100,000 Units/g       Do.                                        
AADA 62-809             Cephalexin Capsules USP, 250 mg and 500 mg   Purepac Pharmaceutical.                    
AADA 62-942             Cyclacilin, bulk drug                        ACS Dobfar SpA.                            
ANDA 70-580             Allopurinol Tablets, USP, 300 mg             Purepac Pharmaceutical.                    
ANDA 71-085             Betamethasone Dipropionate Lotion USP,       Alpharma.                                  
                         0.05%                                                                                  
ANDA 71-798             Triprolidine and Pseudo-ephedrine            KV Pharmaceutical Co., 2503 South Hanley   
                         Hydrochlorides Extended-Release Capsules,    Rd., St. Louis, MO 63144-2555.            
                         5 mg/120 mg                                                                            
ANDA 71-924             Clorazepate Dipotassium Capsules, 3.75 mg    Purepac Pharmaceutical.                    
ANDA 71-925             Clorazepate Dipotassium Capsules, 7.5 mg     Do.                                        
ANDA 71-926             Clorazepate Dipotassium Capsules, 15 mg      Do.                                        
ANDA 80-087             Sulfisoxazole Tablets USP, 500 mg            Do.                                        
ANDA 80-395             Hydrocortisone Tablets, 20 mg                Do.                                        
ANDA 83-271             Niacin Tablets, 500 mg                       Do.                                        
ANDA 84-020             Triamcinolone Tablets USP, 4 mg              Do.                                        
ANDA 84-247             Hydrocortisone Tablets, 10 mg                Do.                                        
ANDA 84-804             Meprobamate Tablets USP, 200 mg and 400 mg   Do.                                        
ANDA 84-939             Chlordiazepoxide Hydrochloride Capsules      Do.                                        
                         USP, 10 mg                                                                             
ANDA 85-144             Chlordiazepoxide Hydrochloride Capsules      Do.                                        
                         USP, 25 mg                                                                             
ANDA 85-155             Chlordiazepoxide Hydrochloride Capsules      Do.                                        
                         USP, 5 mg                                                                              
ANDA 85-753             Liothyronine Sodium Tablets, 50 micrograms   Bolar Pharmaceutical Co., Inc., 130 Lincoln
                                                                      St., Copiague, NY 11726.                  
ANDA 85-904             Isoproterenol Hydrochloride Inhalation       Alpharma.                                  
                         Aerosol USP, 0.25%                                                                     
ANDA 86-110             Sustachron (Nitroglycerin Extended-release)  Forest Laboratories, Inc., 909 Third Ave., 
                         Oral Tablets, 6.5 mg                         New York, NY 10022-4731.                  
ANDA 86-112             Sustachron (Nitroglycerin Extended-release)  Do.                                        
                         Oral Tablets, 2.6 mg                                                                   
ANDA 86-649             Sustachron (Nitroglycerin) Tablets, 10 mg    Do.                                        
ANDA 87-110             Nitroglycerin Extended-release Capsules      KV Pharmaceutical Co.                      
ANDA 87-683             Pentaerythritol Tetra-nitrate Extended-      Inwood Laboratories, Inc., 909 Third Ave., 
                         release Capsules, 80 mg                      New York, NY 10022-4731.                  
ANDA 87-995             THEO-DUR (Theophylline Sustained-release     Schering Corp., 2000 Galloping Hill Rd.,   
                         Capsules) Sprinkle, 200 mg                   Kenilworth, NJ 07033.                     

[[Page 50390]]

                                                                                                                
ANDA 88-015             THEO-DUR (Theophylline Sustained-release     Do.                                        
                         Capsules) Sprinkle, 75 mg                                                              
ANDA 88-016             THEO-DUR (Theophylline Sustained-release     Do.                                        
                         Capsules) Sprinkle, 125 mg                                                             
ANDA 88-022             THEO-DUR (Theophylline Sustained-release     Do.                                        
                         Capsules) Sprinkle, 50 mg                                                              
ANDA 88-066             Hydrocone Bitartrate and Homatropine         Halsey Drug Co., 1827 Pacific St.,         
                         Methylbromide Syrup, 5 mg/1.5 mg per5 mL     Brooklyn, NY 11233.                       
ANDA 88-112             Tripodrine (Triprolidine and                 Danbury Pharmacal, Inc., 131 West St.,     
                         Pseudoephedrine Hydrochlorides Tablets       Danbury, CT 06810.                        
                         USP) 2.5 mg/60 mg                                                                      
ANDA 88-140             Chlorthalidone Tablets USP, 50 mg            Purepac Pharmaceutical.                    
ANDA 88-178             Hydralazine Hydrochloride Tablets, 50 mg     Do.                                        
ANDA 88-360             Fluocinolone Acetonide Cream USP, 0.025%     Alpharma.                                  
ANDA 88-361             Fluocinolone Acetonide Cream USP, 0.01%      Do.                                        
ANDA 88-950             Tolbutamide Tablets, 500 mg                  Purepac Pharmaceutical.                    
ANDA 88-997             Dexamethasone Elixir USP, 0.5 mg/5 mL        Alpharma.                                  
ANDA 89-754             Hydrocortisone Cream USP, 2.5%               Do.                                        
ANDA 89-840             Procainamide Hydrochloride Extended-release  Inwood Laboratories.                       
                         Tablets, 500 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 
September 25, 1997.

    Dated: September 11, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-25369 Filed 9-24-97; 8:45 am]
BILLING CODE 4160-01-F