[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