[Federal Register Volume 62, Number 234 (Friday, December 5, 1997)]
[Notices]
[Pages 64385-64387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31879]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0480]


Zenith Goldline Pharmaceuticals; Withdrawal of Approval of 11 
Abbreviated Antibiotic Applications and 105 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 11 abbreviated antibiotic applications (AADA's) and 105 abbreviated 
new drug applications (ANDA's). Zenith Goldline Pharmaceuticals 
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withdrawn.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: January 5, 1998.
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: Zenith Goldline Pharmaceuticals, 140 Legrand 
Ave., Northvale, NJ 07647, has informed FDA that the drug products 
listed in the following table are no longer marketed and has requested 
that FDA withdraw approval of the applications. Zenith Goldline 
Pharmaceuticals has also, by its request, waived its opportunity for a 
hearing.

                                                                        
------------------------------------------------------------------------
           Application No.                            Drug              
------------------------------------------------------------------------
AADA 60-072..........................  Penicillin G Potassium Powder,   
                                        100,000 units/5 milliliters     
                                        (mL), 200,000 units/5 mL,       
                                        250,000 units/5 mL, 400,000     
                                        units/5 mL, 500,000 units/5 mL  
AADA 60-073..........................  Penicillin G Potassium Tablets   
                                        USP, 100,000 units/Tab, 200,000 
                                        units/Tab, 250,000 units/Tab,   
                                        400,000 units/Tab, 500,000 units/
                                        Tab                             
AADA 60-104..........................  Chlortetracycline Hydrochloride  
                                        (HCl) Capsules USP, 250         
                                        milligrams (mg)                 
AADA 60-518..........................  Penicillin V Potassium Tablets   
                                        USP, 125 mg, 250 mg, 500 mg     
AADA 60-519..........................  Penicillin V Potassium Powder,   
                                        125 mg/5 mL, 250 mg/5 mL        
AADA 60-692..........................  Ampicillin Capsules USP          
                                        (Trihydrate), 250 mg, 500 mg    
AADA 60-765..........................  Ampicillin Capsules USP          
                                        (Trihydrate), 250 mg, 500 mg    
AADA 61-183..........................  Ampicillin for Oral Suspension   
                                        USP, 125 mg/5 mL, 250 mg/5 mL   
AADA 61-468..........................  Tetracycline Syrup, 125 mg/5 mL  
AADA 62-237..........................  Erythromycin Estolate Capsules   
                                        USP, 250 mg                     
AADA 62-762..........................  Cephradine Capsules USP, 250 mg, 
                                        500 mg                          
ANDA 70-360..........................  Diazepam Tablets USP, 2 mg       
ANDA 70-361..........................  Diazepam Tablets USP, 5 mg       
ANDA 70-362..........................  Diazepam Tablets USP, 10 mg      
ANDA 70-935..........................  Perphenazine and Amitriptyline   
                                        HCl Tablets USP, 2 mg/10 mg     
ANDA 70-936..........................  Perphenazine and Amitriptyline   
                                        HCl Tablets USP, 2 mg/25 mg     
ANDA 70-937..........................  Perphenazine and Amitriptyline   
                                        HCl Tablets USP, 4 mg/10 mg     
ANDA 70-938..........................  Perphenazine and Amitriptyline   
                                        HCl Tablets USP, 4 mg/25 mg     
ANDA 70-939..........................  Perphenazine and Amitriptyline   
                                        HCl Tablets USP, 4 mg/50 mg     
ANDA 71-154..........................  Ibuprofen Tablets USP, 200 mg    
                                        (Round)                         
ANDA 71-458..........................  Methyldopa and                   
                                        Hydrochlorothiazide Tablets USP,
                                        250 mg/15 mg                    
ANDA 71-459..........................  Methyldopa and                   
                                        Hydrochlorothiazide Tablets USP,
                                        250 mg/25 mg                    
ANDA 71-460..........................  Methyldopa and                   
                                        Hydrochlorothiazide Tablets USP,
                                        500 mg/30 mg                    
ANDA 71-461..........................  Methyldopa and                   
                                        Hydrochlorothiazide Tablets USP,
                                        500 mg/50 mg                    
ANDA 71-552..........................  Propranolol HCl and              
                                        Hydrochlorothiazide Tablets USP,
                                        40 mg/25 mg                     
ANDA 71-553..........................  Propranolol HCl and              
                                        Hydrochlorothiazide Tablets USP,
                                        80 mg/25 mg                     
ANDA 72-040..........................  Ibuprofen Tablets USP, 200 mg    
                                        (Caplet)                        
ANDA 72-063..........................  Propranolol HCl Tablets USP, 10  
                                        mg                              
ANDA 72-066..........................  Propranolol HCl Tablets USP, 20  
                                        mg                              
ANDA 72-067..........................  Propranolol HCl Tablets USP, 40  
                                        mg                              
ANDA 72-068..........................  Propranolol HCl Tablets USP, 60  
                                        mg                              
ANDA 72-069..........................  Propranolol HCl Tablets USP, 80  
                                        mg                              
ANDA 80-078..........................  Nitrofurantoin Tablets           
                                        (Microcrystalline) 50 mg, 100 mg
ANDA 80-143..........................  Trisulfapyrimidines Tablets USP  
ANDA 80-215..........................  Propylthiouracil Tablets USP, 50 
                                        mg                              
ANDA 80-270..........................  Isoniazid Tablets USP, 100 mg    
ANDA 80-283..........................  Prednisone Tablets USP, 5 mg     
ANDA 80-378..........................  Prednisolone Tablets USP, 5 mg   
ANDA 80-630..........................  Cortisone Acetate Tablets USP, 25
                                        mg                              
ANDA 80-735..........................  Dimenhydrinate Tablets USP, 50 mg
ANDA 80-762..........................  Diphenhydramine HCl Capsules USP,
                                        25 mg, 50 mg                    
ANDA 80-779..........................  Chlorphenirarnine Maleate Tablets
                                        USP, 4 mg                       
ANDA 83-035..........................  Vitamin A Capsules USP, 50,000   
                                        units                           
ANDA 83-077..........................  Propoxyphene Compound Capsules   

[[Page 64386]]

                                                                        
ANDA 83-180..........................  Niacin Tablets USP, 500 mg       
ANDA 83-190..........................  Vitamin A Palmitate Capsules,    
                                        50,000 units                    
ANDA 83-416..........................  Dexamethasone Tablets USP, 0.75  
                                        mg                              
ANDA 83-461..........................  Pentobarbital Sodium Capsules    
                                        USP, 50 mg, 100 mg              
ANDA 83-484..........................  Butabarbital Sodium Tablets USP, 
                                        15 mg                           
ANDA 83-536..........................  Cortisone Acetate Tablets USP, 25
                                        mg                              
ANDA 83-549..........................  Chlorpromazine HCl Tablets USP,  
                                        10 mg, 25 mg, 50 mg             
ANDA 83-568..........................  Reserpine and Hydrochlorothiazide
                                        Tablets USP, 0.1 mg/50 mg       
ANDA 83-570..........................  Chlordiazepoxide HCl Capsules    
                                        USP, 25 mg                      
ANDA 83-571..........................  Reserpine and Hydrochlorothiazide
                                        Tablets USP, 0.125 mg/25 mg     
ANDA 83-572..........................  Reserpine and Hydrochlorothiazide
                                        Tablets USP, 0.1 mg/25 mg       
ANDA 83-573..........................  Reserpine and Hydrochlorothiazide
                                        Tablets USP, 0.125 mg/50 mg     
ANDA 83-574..........................  Chlorpromazine HCl Tablets USP,  
                                        100 mg                          
ANDA 83-575..........................  Chlorpromazine HCl Tablets USP,  
                                        200 mg                          
ANDA 83-597..........................  Propoxyphene HCl Capsules USP, 32
                                        mg                              
ANDA 83-603..........................  Promethazine HCl Tablets USP, 25 
                                        mg                              
ANDA 83-604..........................  Promethazine HCl Tablets USP,    
                                        12.5 mg                         
ANDA 83-610..........................  Isoniazid Tablets USP, 300 mg    
ANDA 83-613..........................  Promethazine HCl Tablets USP, 50 
                                        mg                              
ANDA 83-741..........................  Chlordiazepoxide HCl Capsules    
                                        USP, 5 mg                       
ANDA 83-742..........................  Chlordiazepoxide HCl Capsules    
                                        USP, 10 mg                      
ANDA 83-750..........................  Triamcinolone Tablets USP, 4 mg  
ANDA 83-784..........................  Meclizine HCl Tablets USP, 12.5  
                                        mg                              
ANDA 83-876..........................  Hydralazine HCl and              
                                        Hydrochlorothiazide Tablets, 25 
                                        mg/15 mg                        
ANDA 83-877..........................  Reserpine, Hydralazine HCl, and  
                                        Hydrochlorothiazide Tablets USP,
                                        0.1 mg/25 mg/15 mg              
ANDA 84-040..........................  Butabarbital Sodium Tablets USP, 
                                        30 mg                           
ANDA 84-133..........................  Prednisone Tablets USP, 10 mg    
ANDA 84-134..........................  Prednisone Tablets USP, 20 mg    
ANDA 84-181..........................  Meprobamate Tablets USP, 600 mg  
ANDA 84-291..........................  Reserpine, Hydralazine HCl and   
                                        Hydrochlorothiazide Tablets USP,
                                        0.1 mg/25 mg/15 mg              
ANDA 84-351..........................  Brompheniramine Maleate Tablets  
                                        USP, 4 mg                       
ANDA 84-437..........................  Hydralazine HCl Tablets USP, 25  
                                        mg                              
ANDA 84-443..........................  Hydralazine HCl Tablets USP, 10  
                                        mg                              
ANDA 84-469..........................  Hydralazine HCl Tablets USP, 50  
                                        mg                              
ANDA 84-473..........................  Isosorbide Dinitrate Sublingual  
                                        Tablets USP, 2.5 mg             
ANDA 84-474..........................  Isosorbide Dinitrate Sublingual  
                                        Tablets USP, 5 mg               
ANDA 84-549..........................  Quinidine Sulfate Tablets USP,   
                                        200 mg                          
ANDA 84-581..........................  Hydralazine HCl Tablets USP, 100 
                                        mg                              
ANDA 84-648..........................  Methocarbamol Tablets USP, 500 mg
ANDA 84-649..........................  Methocarbamol Tablets USP, 750 mg
ANDA 84-658..........................  Hydrochlorothiazide Tablets USP, 
                                        50 mg                           
ANDA 84-689..........................  Bethanechol Chloride Tablets USP,
                                        25 mg                           
ANDA 84-976..........................  Meclizine HCl Tablets USP, 25 mg 
ANDA 85-273..........................  Triprolidine and Pseudoephedrine 
                                        Hydrochlorides Tablets USP, 2.5 
                                        mg/60 mg                        
ANDA 85-441..........................  Butalbital Compound Tablets USP, 
                                        50 mg/325 mg                    
ANDA 85-553..........................  Phenterimine HCl Tablets, 8 mg   
ANDA 85-611..........................  Phendimetrazine Tartrate Tablets 
                                        USP, 35 mg                      
ANDA 85-612..........................  Phendimetrazine Tartrate Tablets 
                                        USP, 35 mg                      
ANDA 85-682..........................  Phendimetrazine Tartrate Tablets 
                                        USP, 35 mg                      
ANDA 85-869..........................  Secobarbital Sodium Capsules USP,
                                        100 mg                          
ANDA 86-035..........................  Isosorbide Dinitrate Tablets USP,
                                        10 mg                           
ANDA 86-329..........................  Phentermine HCl Capsules USP, 30 
                                        mg                              
ANDA 87-004..........................  Spironolactone and               
                                        Hydrochlorothiazide Tablets USP,
                                        25 mg/25 mg                     
ANDA 87-008..........................  Dipyridamole Tablets USP, 25 mg  
ANDA 87-108..........................  Spironolactone Tablets USP, 25 mg
ANDA 87-186..........................  Ergoloid Mesylates Tablets USP   
                                        (Sublingual), 0.5 mg            
ANDA 87-216..........................  Hydroxyzine HCl Tablets USP, 10  
                                        mg                              
ANDA 87-316..........................  Dipyridamole Tablets USP, 50 mg  
ANDA 87-320..........................  Dipyridamole Tablets USP, 75 mg  
ANDA 87-353..........................  Chlorpropamide Tablets USP, 250  
                                        mg                              
ANDA 87-410..........................  Hydroxyzine HCl Tablets USP, 25  
                                        mg                              
ANDA 87-411..........................  Hydroxyzine HCl Tablets USP, 50  
                                        mg                              
ANDA 87-555..........................  Chlorthalidone Tablets USP, 25 mg
ANDA 87-769..........................  Sulfinpyrazone Tablets USP, 100  
                                        mg                              
ANDA 87-786..........................  Methyclothiazine Tablets USP, 5  
                                        mg                              
ANDA 87-947..........................  Chlorthalidone Tablets USP, 50 mg
ANDA 88-218..........................  Phenylbutazone Capsules USP, 100 
                                        mg                              
ANDA 88-356..........................  Hydralazine HCl and              
                                        Hydrochlorothiazide Capsules, 25
                                        mg/25 mg                        
ANDA 88-357..........................  Hydralazine HCl and              
                                        Hydrochlorothiazide Capsules, 50
                                        mg/50 mg                        
ANDA 88-358..........................  Hydralazine HCl and              
                                        Hydrochlorothiazide Capsules,   
                                        100 mg/50 mg                    
ANDA 88-840..........................  Chlorpropamide Tablets USP, 100  
                                        mg                              

[[Page 64387]]

                                                                        
ANDA 88-932..........................  Reserpine and Hydroflumethiazide 
                                        Tablets, 0.125 mg/50 mg         
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    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research (21 CFR 5.82), 
approval of the applications listed in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
January 5, 1998.
    Dated: November 17, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-31879 Filed 12-4-97; 8:45 am]
BILLING CODE 4160-01-F