[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Notices]
[Pages 63347-63349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0479]


Parke-Davis et al.; Withdrawal of Approval of 18 New Drug 
Applications, 7 Abbreviated Antibiotic Applications, and 53 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 18 new drug applications (NDA's), 7 abbreviated antibiotic 
applications (AADA's), and 53 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that the approval of the applications be withdrawn.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:  December 29, 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, by their request, waived 
their opportunity for a hearing.

                                                                                                                
----------------------------------------------------------------------------------------------------------------
          Application No.                             Drug                                Applicant             
----------------------------------------------------------------------------------------------------------------
NDA 6-413..........................  Super Anahist (neohetramine            Parke-Davis, 2800 Plymouth Rd., Ann 
                                      hydrochloride).                        Arbor, MI 48105.                   
NDA 7-812..........................  Inhiston-APC (aspirin 3.5 grains       Plough, Inc., P.O. Box 377, Memphis,
                                      (gr), caffeine 0.5 gr, phenacetin      TN 38151.                          
                                      2.5 gr, pheniramine maleate 10                                            
                                      milligrams (mg).                                                          
NDA 9-108..........................  Rauval (rauwolfia serpentina) Tablets  Glenwood-Palisades, P.O. Box 369,   
                                                                             One New England Ave., Piscataway,  
                                                                             NY 08855.                          
NDA 11-760.........................  Normacol (polycarbophil) Tablets.....  Schering Corp., 2000 Galloping Hill 
                                                                             Rd., Kenilworth, NY 07033.         
NDA 11-935.........................  Actifed (pseudoephedrine               Glaxo Wellcome Inc., Five Moore Dr.,
                                      hydrochloride and triprolidine         Research Triangle Park, NC 27709.  
                                      hydrochloride) Syrup.                                                     
NDA 11-936.........................  Actifed (pseudoephedrine               Do.                                 
                                      hydrochloride and triprolidine                                            
                                      hydrochloride) Tablets.                                                   
NDA 11-950.........................  Tacaryl (methdilazine hydrochloride)   Westwood-Squibb Pharmaceuticals,    
                                      Syrup, 4 mg/15 milliliters (mL).       Inc., 100 Forest Ave., Buffalo, NY 
                                                                             14213-1091.                        
NDA 12-939.........................  Neutrapen (penicillinase injectable).  3M Pharmaceuticals, Bldg. 260-6A-22,
                                                                             3M Center, St. Paul, MN 55144-1000.
NDA 15-438.........................  Meprobamate Tablets USP, 200 mg, 400   Zenith Goldline Pharmaceuticals, 140
                                      mg.                                    Legrand Ave., Northvale, NJ 07647. 
NDA 16-649.........................  Feminone Tablets.....................  Pharmacia & Upjohn, 7000 Portage    
                                                                             Rd., Kalamazoo, MI 49001-0199.     
NDA 17-369.........................  Teldrin (chlorpheniramine maleate      SmithKline Beecham Consumer         
                                      extended release) Spansules.           Healthcare, 1500 Littleton Rd.,    
                                                                             Parsippany, NY 07054-3884.         
NDA 17-906.........................  Lactulose Syrup......................  Solvay Pharmaceuticals, Inc., 901   
                                                                             Sawyer Rd., Marietta, GA 30062.    
NDA 19-014.........................  Benylin Decongestant Cough Formula     Warner-Lambert Co., 170 Tabor Rd.,  
                                      (diphenhydramine hydrocholoride and    Morris Plains, NJ 07950.           
                                      pseudoephedrine hydrochloride).                                           
NDA 50-125.........................  Tablets Remanden-250 (Potassium        Merck & Co., Inc., BLA-30, West     
                                      Penicillin G with Probenecid).         Point, PA 19486.                   
NDA 50-137.........................  Cer-O-Cillin Sodium (crystalline       Pharmacia & Upjohn                  
                                      sodium penicillin O).                                                     

[[Page 63348]]

                                                                                                                
NDA 50-298.........................  Pyopen (sterile carbenicillin          SmithKline Beecham Pharmaceuticals, 
                                      disodium) Injection.                   P.O. Box 7929, Philadelphia, PA    
                                                                             19101-7929.                        
NDA 50-375.........................  Cremomycin Oral Suspension...........  Merck & Co., Inc.                   
NDA 50-566.........................  Sterile Cefazolin Sodium Injection in  Baxter Healthcare Corp., Rt. 120 and
                                      PL146 Plastic Container.               Wilson Rd., Round Lake, IL 60073-  
                                                                             0490.                              
AADA 60-571........................  MYCOSTATIN (Nystatin) Ointment         Westwood-Squibb Pharmaceuticals,    
                                      100,000 USP units per gram (g).        Inc.                               
AADA 60-634........................  Oxytetracycline Hydrochloride          Purepac Pharmaceutical Co., 200     
                                      Capsules USP, 250 mg.                  Elmora Ave., Elizabeth, NJ 07207.  
AADA 62-471........................  Gentamicin Sulfate Cream, USP 0.1%...  Alpharma, U.S. Pharmaceuticals Div.,
                                                                             Johns Hopkins Bayview Center, 333  
                                                                             Cassell Dr., suite 3500, Baltimore,
                                                                             MD 21224.                          
AADA 62-496........................  Gentamicin Sulfate Ointment, USP 0.1%  Do.                                 
AADA 62-583........................  Bacitracin (sterile).................  Alpharma AS, U.S. Agent: Alpharma   
                                                                             Inc., One Executive Dr., P.O. Box  
                                                                             1399, Fort Lee, NJ 07024.          
AADA 62-584........................  Bacitracin Zinc (nonsterile).........  Do.                                 
AADA 63-250........................  Amoxicillin Trihydrate, nonsterile     Ranbaxy Laboratories Ltd., U.S.     
                                      bulk.                                  Agent: Ranbaxy Pharmaceuticals,    
                                                                             Inc., 4600 Marriott Dr., suite 100,
                                                                             Raleigh, NC 27612.                 
ANDA 70-136........................  Propranolol Hydrochloride Injection    SoloPak Laboratories, 1845 Tonne    
                                      USP, 1 mg/mL (syringe).                Rd., Elk Grove Village, IL 60007-  
                                                                             5125.                              
ANDA 70-579........................  Allopurinol Tablets USP, 100 mg......  Purepac Pharmaceutical Co.          
ANDA 70-688........................  Methyldopa and Hydrochlorothiazide     Do.                                 
                                      Tablets USP, 250 mg/25 mg.                                                
ANDA 70-695........................  Verapamil Hydrochloride Injection      SoloPak Laboratories                
                                      USP, 2.5 mg/mL (syringe).                                                 
ANDA 70-800........................  Haloperidol Injection USP, 5 mg/mL     Do.                                 
                                      (syringe).                                                                
ANDA 70-853........................  Methyldopa and Hydrochlorothiazide     Purepac Pharmaceutical Co.          
                                      Tablets USP, 250 mg/15 mg.                                                
ANDA 70-854........................  Methyldopa and Hydrochlorothiazide     Do.                                 
                                      Tablets USP, 250 mg/30 mg.                                                
ANDA 71-000........................  Amantadine Hydrochloride Capsules      Solvay Pharmaceuticals, Inc.        
                                      USP, 100 mg.                                                              
ANDA 71-123........................  Ibuprofen Tablets USP, 300 mg........  Purepac Pharmaceutical Co.          
ANDA 71-124........................  Ibuprofen Tablets USP, 400 mg........  Do.                                 
ANDA 71-125........................  Ibuprofen Tablets USP, 600 mg........  Do.                                 
ANDA 71-672........................  Naloxone Hydrochloride Injection USP,  SoloPak Laboratories                
                                      0.02 mg/mL (syringe).                                                     
ANDA 71-683........................  Naloxone Hydrochloride Injection USP,  Do.                                 
                                      0.4 mg/mL (syringe).                                                      
ANDA 72-110........................  Doxepin Hydrochloride Capsules USP,    Purepac Pharmaceutical Co.          
                                      100 mg.                                                                   
ANDA 72-330........................  Clorazepate Dipotassium Tablets, 3.75  Do.                                 
                                      mg.                                                                       
ANDA 72-331........................  Clorazepate Dipotassium Tablets, 7.5   Do.                                 
                                      mg.                                                                       
ANDA 72-332........................  Clorazepate Dipotassium Tablets, 15    Do.                                 
                                      mg.                                                                       
ANDA 72-386........................  Doxepin Hydrochloride Capsules USP,    Do.                                 
                                      75 mg.                                                                    
ANDA 72-387........................  Doxepin Hydrochloride Capsules USP,    Do.                                 
                                      150 mg.                                                                   
ANDA 80-493........................  Cortisone Acetate Tablets USP, 25 mg.  Do.                                 
ANDA 80-842........................  Rauwolfia Serpentina Tablets USP, 50   Do.                                 
                                      mg and 100 mg.                                                            
ANDA 80-845........................  Diphenhydramine Hydrochloride          Eon Labs Manufacturing, Inc., 227-15
                                      Capsules USP, 25 mg and 50 mg.         North Conduit Ave., Laurelton, NY  
                                                                             11413.                             
ANDA 84-138........................  Phendimetrazine Tartrate Tablets, 35   KV Pharmaceutical Co., 2503 South   
                                      mg (Pink).                             Hanley Rd., St. Louis, MO 63144-   
                                                                             2555.                              
ANDA 84-141........................  Phendimetrazine Tartrate Tablets, 35   Do.                                 
                                      mg.                                                                       
ANDA 84-479........................  Dicyclomine Hydrochloride Syrup USP,   Alpharma, U.S. Pharmaceuticals Div. 
                                      10 mg/5 mL.                                                               
ANDA 84-932........................  Quinidine Sulfate USP, 200 mg          Solvay Pharmaceuticals, Inc.        
                                      (Tablets).                                                                
ANDA 85-296........................  Quinidine Sulfate USP, 200 mg          Do.                                 
                                      (Capsules).                                                               
ANDA 85-297........................  Quinidine Sulfate USP, 300 mg          Do.                                 
                                      (Capsules).                                                               
ANDA 85-298........................  Quinidine Sulfate USP, 300 mg          Do.                                 
                                      (Tablets).                                                                
ANDA 85-299........................  Quinidine Sulfate USP, 100 mg          Do.                                 
                                      (Tablets).                                                                
ANDA 86-298........................  UNIPRES (Reserpine, Hydralazine        Do.                                 
                                      Hydrochloride, and                                                        
                                      Hydrochlorothiazide Tablets, USP)                                         
                                      0.1 mg/25 mg/15 mg.                                                       
ANDA 86-822........................  Hydroxyzine Hydrochloride Injection    SoloPak Laboratories                
                                      USP, 25 mg/mL (syringe).                                                  
ANDA 87-043........................  Heparin Sodium Injection USP, 1,000    Do.                                 
                                      units/mL (syringe).                                                       
ANDA 87-077........................  Heparin Sodium Injection USP, 5,000    Do.                                 
                                      units/mL (syringe).                                                       
ANDA 87-101........................  Isoetharine Inhalation Solution, USP   Alpharma, U.S. Pharmaceuticals Div. 
                                      1%.                                                                       

[[Page 63349]]

                                                                                                                
ANDA 87-107........................  Heparin Sodium Injection USP, 10,000   SoloPak Laboratories                
                                      units/mL (syringe).                                                       
ANDA 87-109........................  Nitroglycerin Extended-Release         KV Pharmaceutical Co.               
                                      Capsules, 9 mg.                                                           
ANDA 87-310........................  Hydroxyzine Hydrochloride Injection    SoloPak Laboratories                
                                      USP, 50 mg/mL.                                                            
ANDA 87-344........................  Isosorbide Dinitrate Extended-release  Inwood Laboratories, Inc., 909 Third
                                      Capsules, 40 mg.                       Ave., New York, NY 10022-4731.     
ANDA 87-363........................  Heparin Sodium Injection USP, 10,000   SoloPak Laboratories                
                                      units/0.5 mL (syringe).                                                   
ANDA 87-395........................  Heparin Sodium Injection USP, 5,000    Do.                                 
                                      units/0.5 mL (syringe).                                                   
ANDA 87-551........................  Cyanocobalamin Injection USP, 1,000    Do.                                 
                                      micrograms/mL (syringe).                                                  
ANDA 87-596........................  Hydroxyzine Hydrochloride Injection    Do.                                 
                                      USP, 50 mg/mL and 100 mg/mL.                                              
ANDA 87-903........................  Heparin Lock Flush Solution USP, 10    Do.                                 
                                      units/mL (syringe).                                                       
ANDA 87-905........................  Heparin Lock Flush Solution USP, 100   Do.                                 
                                      units/mL (syringe).                                                       
ANDA 88-120........................  Hydroxyzine Hydrochloride Tablets      Purepac Pharmaceutical Co.          
                                      USP, 10 mg.                                                               
ANDA 88-121........................  Hydroxyzine Hydrochloride Tablets      Do.                                 
                                      USP, 25 mg.                                                               
ANDA 88-122........................  Hydroxyzine Hydrochloride Tablets      Do.                                 
                                      USP, 50 mg.                                                               
ANDA 88-139........................  Chlorthalidone Tablets USP, 25 mg....  Do.                                 
ANDA 88-177........................  Hydralazine Hydrochloride Tablets, 25  Do.                                 
                                      mg.                                                                       
ANDA 88-520........................  Phenytoin Sodium Injection USP, 50 mg/ SoloPak Laboratories                
                                      mL (syringe).                                                             
ANDA 88-532........................  Procainamide Hydrochloride Injection   Do.                                 
                                      USP, 500 mg/mL (syringe).                                                 
ANDA 89-094........................  Trimethobenzamide Hydrochloride        Do.                                 
                                      Injection USP, 100 mg/mL (syringe).                                       
----------------------------------------------------------------------------------------------------------------

    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 
December 29, 1997.

    Dated: November 17, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-31214 Filed 11-26-97; 8:45 am]
BILLING CODE 4160-01-F