[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Notices]
[Page 5386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0507]


Mountaire Vitamins, Inc., et al.; Withdrawal of Approval of 
NADA's

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of eight new animal drug applications (NADA's) as requested by the 
sponsors. The NADA's provide for use of products that are no longer 
made or marketed. In a final rule published elsewhere in this issue of 
the Federal Register, FDA is amending the regulations by removing the 
entries that reflect approval of the NADA's.

EFFECTIVE DATE: February 12, 1998.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1722.

SUPPLEMENTARY INFORMATION: The following sponsors have requested 
withdrawal of approval of NADA's that provide for use of the animal 
drug products noted:

                                                                        
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                                                       Sponsor name and 
           NADA No.                  Drug name             address      
------------------------------------------------------------------------
38-247........................  Hygromycin B Type A  Mountaire Feeds,   
                                 medicated article.   Inc., 124 East    
                                                      Fifth, P.O. Box   
                                                      5391, North Little
                                                      Rock, AR 72119,   
                                                      formerly Mountaire
                                                      Vitamins, Inc.,   
                                                      400 North Poplar  
                                                      St., P.O. Box     
                                                      9210, North Little
                                                      Rock, AR 72119    
44-013........................  Tylosin Type A       do.                
                                 medicated article.                     
65-273........................  Chloramphenicol      Zenith Goldline    
                                 capsules, USP.       Pharmaceuticals,  
                                                      Inc., 140 Legrand 
                                                      Ave., Northvale,  
                                                      NJ 07647, formerly
                                                      Zenith            
                                                      Laboratories,     
                                                      Inc., 50 Williams 
                                                      Dr., Ramsey, NJ   
                                                      07446             
65-456........................  Tetracycline HCl     do.                
                                 capsules, USP.                         
95-736........................  Hygromycin B Type A  Mountaire Feeds,   
                                 medicated article.   Inc.              
98-895........................  Starbar GX-118       Wellmark           
                                 Topical              International,    
                                 (phosmet)(prolate).  1000 Tower Lane,  
                                                      Bensenville, IL   
                                                      60106, formerly   
                                                      Sandoz Agro, Inc.,
                                                      1300 East Touhy   
                                                      Ave., Des Plaines,
                                                      IL 60018          
137-138.......................  Pyrantel tartrate    Mountaire Feeds,   
                                 Type A medicated     Inc.              
                                 article.                               
139-239.......................  Banminth (pyrantel   Growmark, Inc., 950
                                 tartrate) Type A     North Meridian    
                                 medicated article.   St., Indianapolis,
                                                      IN 46204-3909,    
                                                      formerly at 1701  
                                                      Towanda Ave.,     
                                                      Bloomington, IL   
                                                      61701             
------------------------------------------------------------------------

    The sponsors are requesting withdrawal of approval of the NADA's 
because the products approved under the NADA's are no longer made or 
marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA's 38-247, 44-013, 65-273, 65-456, 95-736, 98-895, 137-
138, and 139-239, and all supplements and amendments thereto is hereby 
withdrawn, effective February 12, 1998.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending 21 CFR 510.600, 520.390b, 520.2345a, 
524.1742, 558.274, 558.485, and 558.625 to reflect the withdrawal of 
approval of these NADA's.

    Dated: January 8, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-2408 Filed 1-30-98; 8:45 am]
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