[Federal Register Volume 59, Number 59 (Monday, March 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7203]


[Federal Register: March 28, 1994]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0107]


Chelsea Laboratories, Inc.; Withdrawal of Approval of 26 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 26 abbreviated new drug applications (ANDA's) held by Chelsea 
Laboratories, Inc., 896 Orlando Ave., West Hempstead, NY 11552 
(Chelsea). Chelsea 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applications be withdrawn.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: April 27, 1994.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug 
Evaluation and Research (HFD-360), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.
SUPPLEMENTARY INFORMATION: Chelsea informed FDA that the drugs listed 
in the table in this document are no longer marketed and requested that 
FDA withdraw approval of the applications. Chelsea has also, by its 
request, waived its opportunity for a hearing.

------------------------------------------------------------------------
             ANDA no.                                Drug               
------------------------------------------------------------------------
70-000                               Sulfamethoxazole and Trimethoprim  
                                      Tablets, U.S.P, 800 milligrams    
                                      (mg)/160 mg                       
70-002                               Sulfamethoxazole and Trimethoprim  
                                      Tablets, U.S.P, 400 mg/80 mg      
71-603                               Clofibrate Capsules, U.S.P., 500 mg
71-635                               Indomethacin Capsules, 50 mg       
85-167                               Procainamide Hydrochloride         
                                      Capsules, U.S.P., 250 mg          
85-815                               Amitriptyline Hydrochloride        
                                      Tablets, 50 mg                    
85-816                               Amitriptyline Hydrochloride        
                                      Tablets, 10 mg                    
85-817                               Amitriptyline Hydrochloride        
                                      Tablets, 25 mg                    
85-819                               Amitriptyline Hydrochloride        
                                      Tablets, 75 mg                    
85-820                               Amitriptyline Hydrochloride        
                                      Tablets, 100 mg                   
86-150                               Probenecid Tablets, 500 mg         
86-151                               Phenylbutazone Tablets, U.S.P., 100
                                      mg                                
86-161                               Methylprednisolone Tablets, 4 mg   
86-237                               Butalbital, Aspirin, and Caffeine  
                                      Tablets, U.S.P., 50 mg/325 mg/40  
                                      mg                                
86-705                               Hydroxyzine Pamoate Capsules,      
                                      U.S.P., 50 mg                     
86-827                               Hydroxyzine Hydrochloride Tablets, 
                                      U.S.P., 10 mg                     
86-829                               Hydroxyzine Hydrochloride Tablets, 
                                      U.S.P., 25 mg                     
86-836                               Hydroxyzine Hydrochloride Tablets, 
                                      U.S.P., 50 mg                     
86-840                               Hydroxyzine Pamoate Capsules,      
                                      U.S.P., 25 mg                     
86-865                               Chlorpropamide Tablets, 100 mg     
87-020                               Procainamide Hydrochloride         
                                      Capsules, U.S.P., 375 mg          
87-021                               Procainamide Hydrochloride         
                                      Capsules, U.S.P., 500 mg          
87-078                               Spironolactone Tablets, 25 mg      
87-082                               Chlorthalidone Tablets, 50 mg      
87-756                               Phenylbutazone Capsules, U.S.P.,   
                                      100 mg                            
87-785                               Quinidine Gluconate Sustained      
                                      Release Tablets, U.S.P., 324 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 ANDA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective April 27, 1994.

    Dated: March 14, 1994.
Roger Williams,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-7203 Filed 3-25-94; 8:45 am]
BILLING CODE 4160-01-F