[Federal Register Volume 60, Number 120 (Thursday, June 22, 1995)]
[Rules and Regulations]
[Pages 32446-32447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15241]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 46 new animal drug 
applications (NADA's) from Sanofi Animal Health, Inc., to Rhone 
Merieux, Inc.

EFFECTIVE DATE: June 22, 1995.

FOR FURTHER INFORMATION CONTACT: Judith M. O'Haro, Center for 
Veterinary Medicine (HFV-238), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1737.

SUPPLEMENTARY INFORMATION: Sanofi Animal Health, Inc., 7101 College 
Blvd., Overland Park, KS 66210, has informed FDA that it has 
transferred ownership of, and all rights and interests in, the 
following approved NADA's to Rhone Merieux, Inc., 7101 College Blvd., 
Overland Park, KS 66210:

                                                                        
------------------------------------------------------------------------
            NADA number                           Drug name             
------------------------------------------------------------------------
006-623............................  Caparsolate                        
008-422............................  Seleen Suspension                  
010-092............................  Gallimycin'-50P Premix             
010-346............................  Combuthal Powder                   
012-123............................  Gallimycin-100, Gallimycin LA      
                                      Injectable, Erythro-200 Injection 
033-157............................  Spectam Scour Halt                 
035-157............................  Gallimycin Poultry Formula         
035-455............................  Gallimycin-36/Dry                  
035-456............................  Gallimycin 36 Sterile              
038-241............................  Erythro +ZOA+ARS Acid              
038-242............................  Erythro +AMP+ETHO                  
038-624............................  Pro-Gallimycin-10                  
038-661............................  Spectam Water Soluble Concentrate  
040-040............................  Spectam Injection                  
041-955............................  Erythromycin Premix                
044-756............................  Butatron Tablets                   
045-416............................  Butatron Injection                 
048-287............................  Oxytetracycline-50 Injection       
055-002............................  Chloramphenicol Injection          
055-059............................  Viceton Tablets                    
065-275............................  Penicillin VK Filmtab              
065-276............................  Veesyn Granules for Oral Solution  
065-383............................  Procaine G Penicillin Mastitis     
                                      Tubes                             
065-384............................  Procaine G Penicillin Mastitis     
                                      Tubes                             
093-483............................  Spectam Injectable                 
093-515............................  Spectam Tablets                    
095-218............................  Dexamethasone Tablets              
097-397............................  Syncro-Mate-B                      
098-379............................  Cystorelin Injectable              
100-128............................  Medipak Tylan 10                   
101-690............................  Erythro-100 Injectable             
102-656............................  Gallimycin Poultry Formula         
107-506............................  Carbam Tablets & Film Coated       
                                      Tablets                           
113-510............................  Equipalazone                       
118-032............................  Carbam Palatabs                    
118-979............................  Butatron Oral Gel                  
119-142............................  Injectable Iron 10%                
120-615............................  Sustain III Calf & Cattle Bolus    
123-815............................  Dexarnethasone Sodium Phosphate    
                                      Injection                         
124-241............................  Oxytocin Injection                 
126-504............................  Nitrozone Ointment                 
128-089............................  Dexamethasone Sterile Solution     
134-930............................  Syncro-Mate-B                      
200-050............................  Neomycin 325 Soluble Powder        
200-103............................  Penicillin G Potassium             
200-147............................  Gentamicin Sulfate Injection       
------------------------------------------------------------------------

    Accordingly, FDA is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) to reflect the change of sponsor. The drug 
labeler code assigned to Sanofi Animal Health, Inc., is being retained 
as the drug labeler code for Rhone Merieux, Inc.

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is 
amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:
    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e). [[Page 32447]] 


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``Sanofi Animal Health, Inc.'' and by 
alphabetically adding a new entry for ``Rhone Merieux, Inc., 7101 
College Blvd., Overland Park, KS 66210......050604'' and in the table 
in paragraph (c)(2) in the entry for ``050604'' by removing the sponsor 
name ``Sanofi Animal Health, Inc.'' and adding in its place ``Rhone 
Merieux, Inc., 7101 College Blvd., Overland Park, KS 66210''.

    Dated: June 12, 1995.
George A. Mitchell,
Director, Office of Surveillance and Compliance, Center for Veterinary 
Medicine.
[FR Doc. 95-15241 Filed 6-21-95; 8:45 am]
BILLING CODE 4160-01-F