[Federal Register Volume 62, Number 147 (Thursday, July 31, 1997)]
[Rules and Regulations]
[Pages 40930-40931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20249]


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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 Solvay Animal Health, Inc., to Fort Dodge 
Animal Health, A Division of American Cyanamid Co.

EFFECTIVE DATE: July 31, 1997.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Solvay Animal Health, Inc., 1201 Northland 
Dr., Mendota Heights, MN 55120, has informed FDA that it has 
transferred the ownership of, and all rights and interests in, the 
following approved NADA's to Fort Dodge Animal Health, A Division of 
American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501:


------------------------------------------------------------------------
                NADA No.                            Drug Name           
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006-417................................  Recovr                         
006-103................................  Follutein                      
006-707................................  Sulquin 6-50                   
008-274................................  Pig Scour Tablets              
009-035................................  Ophtaine                       
011-141................................  Unistat-2                      
011-482................................  Vetame Tabs and Injection      
011-879................................  Rubfrafer Injection            
012-198................................  Vetalog Parenteral             
012-258................................  Panalog Ointment (Solvaderm)   
013-624................................  Vetalog Tabs                   
014-250................................  Novastat                       
031-448................................  Rheaform Bolus                 
031-553................................  Esb3 Powder & Solution         
032-319................................  Furox Aerosol Spray            
032-738................................  Pacitran Soluble               
033-127................................  Vetisulid Bolus                
033-318................................  Vetisulid Injectable           
033-319................................  Vetisulid Tabs                 
033-373................................  Vetisulid Powder               
034-536................................  Aklomix                        
034-537................................  Novastat-3                     
034-705................................  Equipoise                      
035-388................................  Novastat-W                     
039-666................................  Unistat-3                      
040-181................................  Vetisulid Oral Suspension      
046-146................................  Vetalog Cream                  
046-147................................  Dirocide Syrup                 
049-892................................  Spanbolet II                   
055-060................................  Potassium G penicillin         
055-064................................  Redicillin (Princillin)        
055-066................................  Redicillin (Princillin)        
055-071................................  Redicillin (Princillin)        
065-130................................  Crystaline Pro Penicillin      
065-174................................  Crysticillin 300 A.S. Vet      
065-410................................  Tetra-Sal Soluble              
091-192................................  Renografin 76                  
091-240................................  Renovist                       
091-327................................  Gastrogratin                   
093-512................................  Dirocide Tabs                  
096-676................................  Panalog Cream                  
099-388................................  Vetalog Oral Powder            
126-232................................  Calfspan                       
131-808................................  Dirocide Syrup                 

[[Page 40931]]

                                                                        
139-913................................  Equron                         
140-909................................  Sulka-S-Bolus                  
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Accordingly, the agency 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 Solvay Animal Health is being retained as the 
drug labeler code for the new sponsor.

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).

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 ``Solvay Animal Health, Inc.'' and by 
alphabetically adding a new entry for ``Fort Dodge Animal Health, A 
Division of American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 
50501'' and in the table in paragraph (c)(2) in the entry for 
``053501'' by removing the sponsor name and address ``Solvay Animal 
Health, Inc., 1201 Northland Dr., Mendota Heights, MN 55120'' and 
adding in its place ``Fort Dodge Animal Health, A Division of American 
Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501''.

    Dated: July 22, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-20249 Filed 7-30-97; 8:45 am]
BILLING CODE 4160-01-F