96-5213. Animal Drugs, Feeds, and Related Products; Change of Sponsor  

  • [Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)]
    [Rules and Regulations]
    [Pages 8872-8873]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-5213]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Parts 510, 520, 522, and 524
    
    
    Animal Drugs, Feeds, and Related Products; 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 the change of sponsor for 28 approved new 
    animal drug applications (NADA's) from Coopers Animal Health, Inc., to 
    Mallinckrodt Veterinary, Inc.
    
    EFFECTIVE DATE: March 6, 1996.
    
    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: Coopers Animal Health, Inc., 1201 Douglas 
    Ave., Kansas City, KS 66103-1438, has informed FDA that it has 
    transferred the ownership of, and all rights and interests in, the 
    following approved NADA's to Mallinckrodt Veterinary, Inc., Mundelein, 
    IL 60060.
    
                                                                            
    ------------------------------------------------------------------------
      NADA No.             Trade name                 Active ingredient     
    ------------------------------------------------------------------------
    6-602......  A-H Tablets 25 milligrams      Doxylamine Succinate        
                  (mg)/100 mg.                                              
    6-983......  A-H Injection................  Doxylamine Succinate,       
                                                 Chlorobutanol              
    10-987.....  Butazolidin Tablets/Bolus....  Phenylbutazone              
    11-222.....  Diquel Tablets...............  Ethylisobutrazine           
                                                 Hydrochloride              
    11-575.....  Butazolidin Injection 20%....  Phenylbutazone              
    11-877.....  Jenotone Tablets.............  Aminopromazine Fumarate     
    11-893.....  Dermathycin Injection........  Thyroid Stimulating Hormone 
    15-182.....  Canopar Tablets..............  Thenium Closylate           
    13-181.....  Jenomycin Tablets............  Aminopromazine Fumarate,    
                                                 Neomycin Sulfate           
    34-477.....  Jenotone Solution............  Aminopromazine Fumarate     
    35-016.....  Scolaban 400.................  Bunamidine Hydrochloride    
    35-265.....  Diquel Solution..............  Ethylisobutrazine           
                                                 Hydrochloride              
    38-800.....  Butazolidin Granules.........  Phenylbutazone              
    44-757.....  Prolate I-E..................  Phosmet                     
    48-913.....  Halox Wormer Drench..........  Haloxon                     
    65-476.....  Cortisporin Veterinary         Bactricin ZN, Neomycin      
                  Ophthalmic Ointment.           Sulfate, Polymyxin B       
                                                 Sulfate, Hydrocortisone    
                                                 Acetate                    
    65-485.....  Neosporin Ophthalmic Ointment  Bactricin ZN, Neomycin      
                                                 Sulfate, Polymyxin B       
                                                 Sulfate                    
    92-483.....  Halox Bolus..................  Haloxon                     
    95-614.....  Tribrissen 30/120/480/960      Sulfadiazine, Trimethoprim  
                  Tablets.                                                  
    97-288.....  Imizol Equine Injection......  Imidocarb Dipropionate      
    101-161....  Thenatol PW Tablets..........  Thenium Closylate,          
                                                 Piperazine Phosphate       
    105-093....  Tribrissen 24% Injection.....  Trimethoprim, Sulfadiazine  
                                                 Sodium                     
    106-965....  Tribrissen 48% Injection.....  Trimethoprim, Sulfadiazine  
    116-087....  Burazolidin Paste/Butazolidin/ Phenylbutazone              
                   Phenylzone/Bute.                                         
    120-326....  Filban Chewable Wafers.......  Diethylcarbamazine Citrate  
    124-842....  Filban Tablets...............   Diethylcarbamazine Citrate 
    131-918....  Tribrissen 400 Oral Paste....  Trimethoprim, Sulfadiazine  
    136-741....  Tribrissen 60 Oral Suspension  Trimethoprim, Sulfadiazine  
    ------------------------------------------------------------------------
    
        The agency is amending 21 CFR 510.600(c)(1) and (c)(2), and parts 
    520, 522, and 524 to reflect the change of sponsor.
    
    List of Subjects
    
     21 CFR Part 510
    
        Administrative practice and procedure, Animal drugs, Labeling, 
    Reporting and recordkeeping requirements.
    
    21 CFR Parts 520, 522, and 524
    
        Animal drugs.
        -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 parts 510, 
    520, 522, and 524 are 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 is amended in the table in paragraph (c)(1) by 
    removing the entry for ``Coopers Animal Health, Inc.''; and in the 
    table in paragraph (c)(2) by removing the entry for ``017220''.
    
    PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
    
        -3. The authority citation for 21 CFR part 520 continues to read as 
    follows:
    
        Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
    (21 U.S.C. 360b) .
    
    [[Page 8873]]
    
    
    
    Sec. 520.82a   [Amended]
    
         4. Section 520.82a  Aminopropazine fumarate tablets is amended in 
    paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 520.82b   [Amended]
    
         5. Section 520.82b Aminopropazine fumarate, neomycin sulfate 
    tablets is amended in paragraph (b) by removing ``017220'' and adding 
    in its place ``011716''.
    
    
    Sec. 520.222   [Amended]
    
         6. Section 520.222 Bunamidine hydrochloride is amended in 
    paragraph (c) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 520.622c   [Amended]
    
         7. Section 520.622c Diethylcarbamazine citrate chewable tablets is 
    amended in paragraph (b)(5) by removing ``017220'' and adding in its 
    place ``011716''.
    
    
    Sec. 520.784   [Amended]
    
         8. Section 520.784 Doxylamine succinate tablets is amended in 
    paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 520.863   [Amended]
    
         9. Section 520.863 Ethylisobutrazine hydrochloride tablets is 
    amended in paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 520.1120a   [Amended]
    
         10. Section 520.1120a Haloxon drench is amended in paragraph (c) 
    by removing ``017220'' and adding in its place ``011716''.
    
    
    Sec. 520.1120b   [Amended]
    
         11. Section 520.1120b Haloxon boluses is amended in paragraph (c) 
    by removing ``017220'' and adding in its place ``011716''.
    
    
    Sec. 520.1720a   [Amended]
    
         12. Section 520.1720a Phenylbutazone tablets and boluses is 
    amended in paragraph (b)(1) by removing ``017220'' and adding in its 
    place ``011716''.
    
    
    Sec. 520.1720b   [Amended]
    
         13. Section 520.1720b Phenylbutazone granules is amended in 
    paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 520.1720c   [Amended]
    
         14. Section 520.1720c Phenylbutazone paste is amended in paragraph 
    (b) by removing ``017220'' and adding in its place ``011716''.
    
    
    Sec. 520.1805   [Amended]
    
         15. Section 520.1805 Piperazine phosphate with thenium closylate 
    tablets is amended in paragraph (b) by removing ``017220'' and adding 
    in its place ``011716''.
    
    
    Sec. 520.2362   [Amended]
    
         16. Section 520.2362 Thenium closylate tablets is amended in 
    paragraph (c) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 520.2610   [Amended]
    
         17. Section 520.2610 Trimethoprim and sulfadiazine tablets is 
    amended in paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 520.2611   [Amended]
    
         18. Section 520.2611 Trimethoprim and sulfadiazine oral paste is 
    amended in paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 520.2612   [Amended]
    
         19. Section 520.2612 Trimethoprim and sulfadiazine oral suspension 
    is amended in paragraph (b) by removing ``017220'' and adding in its 
    place ``011716''.
    
     PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
    
         20. The authority citation for 21 CFR Part 522 continues to read 
    as follows:
    
        Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
    (21 U.S.C. 360b).
    
    
    Sec. 522.82   [Amended]
    
        -21. Section 522.82 Aminopropazine fumarate sterile solution 
    injection is amended in paragraph (b) by removing ``017220'' and adding 
    in its place ``011716''.
    
    
    Sec. 522.784   [Amended]
    
        -22. Section 522.784 Doxylamine succinate injection is amended in 
    paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 522.863   [Amended]
    
        -23. Section 522.863 Ethylisobutrazine hydrochloride injection is 
    amended in paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 522.1155   [Amended]
    
        -24. Section 522.1155 Imidocarb dipropionate sterile powder is 
    amended in paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 522.1720   [Amended]
    
        -25. Section 522.1720 Phenylbutazone injection is amended in 
    paragraph (b)(1) by removing ``017220'' and adding in its place 
    ``011716''.
    
    
    Sec. 522.2610   [Amended]
    
        -26. Section 522.2610 Trimethoprim and sulfadiazine sterile 
    suspension is amended in paragraphs (a)(2) and (b)(2) by removing 
    ``017220'' and adding in its place ``011716''.
    
    PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
    
        -27. The authority citation for 21 CFR part 524 continues to read 
    as follows:
    
        Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
    (21 U.S.C. 360b).
    
    
    Sec. 524.154   [Amended]
    
        -28. Section 524.154 Bacitracin or bacitracin zinc-neomycin 
    sulfate-polymyxin B sulfate ophthalmic ointment is amended in paragraph 
    (a)(2) by removing ``017220'' and adding in its place ``011716''.
    
    
    Sec. 524.155   [Amended]
    
        -29. Section 524.155 Bacitracin zinc-polymyxin B sulfate neomycin 
    sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment is 
    amended in paragraph (a)(1) by removing ``017220'' and adding in its 
    place ``011716''.
    
    
    Sec. 524.1742   [Amended]
    
        -30. Section 524.1742 N-(Mercaptomethyl) phthalimide S-(O,O-
    dimethyl phosphorodithioate) emulsifiable liquid is amended in 
    paragraph (b) by removing ``017220'' and adding in its place 
    ``011716''.
    
        Dated: February 28, 1996.
    Robert C. Livingston,
    Director, Office of New Animal Drug Evaluation, Center for Veterinary 
    Medicine.
    [FR Doc. 96-5213 Filed 3-5-96; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Effective Date:
3/6/1996
Published:
03/06/1996
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-5213
Dates:
March 6, 1996.
Pages:
8872-8873 (2 pages)
PDF File:
96-5213.pdf
CFR: (26)
21 CFR 510.600
21 CFR 520.222
21 CFR 520.784
21 CFR 520.863
21 CFR 520.1805
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