[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.
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NADA No. Trade name Active ingredient
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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
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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
