[Federal Register Volume 61, Number 30 (Tuesday, February 13, 1996)]
[Rules and Regulations]
[Pages 5505-5507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3078]
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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 a change of sponsor for 35 approved new
animal drug applications (NADA's) from Syntex Animal Health, Division
of Syntex Agri-business, Inc., to Fort Dodge Laboratories, Division of
American Home Products.
EFFECTIVE DATE: February 13, 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: Syntex Animal Health, Division of Syntex
Agri-business, Inc., 3401 Hillview Ave., Palo Alto, CA 94303, has
informed FDA that it has transferred the ownership of, and all rights
and interests in, the following approved NADA's to Fort Dodge
Laboratories, Division of American Home Products Corp., 800 Fifth St.
NW., Fort Dodge, IA 50501:
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NADA No. Drug Name
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9-576................... Synovex S and Synovex C Implants (progesterone and estradiol
benzoate)
11-427.................. Synovex H Implants (testosterone propionate and estradiol benzoate)
15-126.................. Spectinomycin Injectable & Tablets (spectinomycin)
30-414.................. Flucort (V Solution (flumethasone)
30-415.................. Flucort Tablets (flumethasone)
32-168.................. DOMOSO Solution (dimethyl sulfoxide)
36-211.................. Anaprime Suspension (flumethasone)
36-212.................. Fluosmin Suspension (flumethasone acetate)
37-586.................. Erythromast '36' Solution (erythromycin)
38-801.................. Anaprime Ophthalmic Solution (flumethasone)
41-629.................. Spectinomycin Oral Solution and Spectogard Oral Solution
(spectinomycin)
41-665.................. Tranvet Chewable Tablets (propiopromazine hydrochloride)
45-512.................. Synotic Otic Solution (fluocinolone acetonide and dimethyl sulfoxide)
45-716.................. Tranvet Injectable Solution (propiopromazine hydrochloride)
47-334.................. Synsac Solution (flucinolone acetonide and dimethyl sulfoxide)
47-925.................. DOMOSO Gel (dimethyl sulfoxide)
49-725.................. Anaprime Opthakote Ophthalmic Solution (flumethasone with neomycin
sulfate and polymyxin B sulfate)
[[Page 5506]]
49-726.................. Optiprime Opthakote Ophthalmic Solution (neomycin sulfate and
polymyxin B sulfate)
96-674.................. Equiproxen Granules (naproxen)
96-675.................. Equiproxen Injectable (naproxen)
100-254................. Synchrocept (prostalene)
110-776................. Benzelmin Powder for Suspension (oxfendazole)
110-777................. Benzelmin Top Dress Pellets (oxfendazole)
115-578................. Di-Trim Tablets (trimethoprim and sulfadiazine)
128-549................. Bovilene Sterile Solution (fenprostalene)
128-967................. Repose (sodium secobarbital and dibucaine hydrochloride)
132-105................. Benzelmin 37.5% Paste (oxfendazole)
132-486................. Di-Trim 24% Injection (trimethoprim and sulfadiazine)
133-841................. Benzelmin 9.06% Suspension (oxfendazole)
134-778................. Di-Trim 48% Injection (trimethoprim and sulfadiazine)
136-342................. Di-Trim 400 Oral Paste (trimethoprim and sulfadiazine)
136-740................. Benzelmin Plus Paste (oxfendazole plus trichlorfon)
138-903................. Porcilene Sterile Solution (fenprostalene)
140-854................. Synanthic 9.06% and 22.5% Suspension(oxfendazole)
140-892................. Synanthic 18.5% Paste (oxfendazole)
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Accordingly, the agency is amending 21 CFR parts 510, 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 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) by revising the entry for ``Fort Dodge Laboratories'' to read
``Fort Dodge Laboratories, Division of American Home Products Corp.,
800 Fifth St. NW., Fort Dodge, IA 50501''; and in the table in
paragraph (c)(2) in the entry for ``000856'' by revising the sponsor
name and address to read, ``Fort Dodge Laboratories, Division of
American Home Products, 800 Fifth St. NW., Fort Dodge, IA 50501.''
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) .
Sec. 520.960 [Amended]
4. Section 520.960 Flumethasone tablets is amended in paragraph (b)
by removing ``000033'' and adding in its place ``000856''.
Sec. 520.1468 [Amended]
5. Section 520.1468 Naproxen granules is amended in paragraph (b)
by removing ``000033'' and adding in its place ``000856''.
Sec. 520.1628 [Amended]
6. Section 520.1628 Oxfendazole powder and pellets is amended in
paragraph (b) by removing ``000033'' and adding in its place
``000856''.
Sec. 520.1629 [Amended]
7. Section 520.1629 Oxfendazole paste is amended in paragraph
(a)(2) and (b)(2) by removing ``000033'' and adding in its place
``000856''.
Sec. 520.1630 [Amended]
8. Section 520.1630 Oxfendazole suspension is amended in paragraph
(b) by removing ``000033'' and adding in its place ``000856''.
Sec. 520.1631 [Amended]
9. Section 520.1631 Oxfendazole and trichlorfon paste is amended in
paragraph (b) by removing ``000033'' and adding in its place
``000856''.
Sec. 520.2002 [Amended]
10. Section 520.2002 Propiopromazine hydrochloride is amended in
paragraph (c) by removing ``000033'' and adding in its place
``000856''.
Sec. 520.2122 [Amended]
11. Section 520.2122 Spectinomycin dihydrochloride oral solution
is amended in paragraph (b)(2) by removing ``000033'' and adding in its
place ``000856''.
Sec. 520.2610 [Amended]
12. Section 520.2610 Trimethoprim and sulfadiazine tablets is
amended in paragraph (b) by removing ``000033'' and adding in its place
``000856''.
Sec. 520.2611 [Amended]
13. Section 520.2611 Trimethoprim and sulfadiazine oral paste is
amended in paragraph (b) by removing ``000033'' and adding in its place
``000856''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
14. 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. 522.842 [Amended]
15. Section 522.842 Estradiol benzoate and testosterone propionate
in combination is amended in paragraph (b) by removing ``000033'' and
adding in its place ``000856''.
Sec. 522.914 [Amended]
16. Section 522.914 Fenprostalene solution is amended in paragraph
(b) by removing ``000033'' and adding in its place ``000856''.
Sec. 522.960a [Amended]
17. Section 522.960a Flumethasone suspension is amended in
paragraph (c)
[[Page 5507]]
by removing ``000033'' and adding in its place ``000856''.
Sec. 522.960b [Amended]
18. Section 522.960b Flumethasone acetate injection is amended in
paragraph (c) by removing ``000033'' and adding in its place
``000856''.
Sec. 522.960c [Amended]
19. Section 522.960c Flumethasone solution is amended in paragraph
(b) by removing ``000033'' and adding in its place ``000856''.
Sec. 522.1468 [Amended]
20. Section 522.1468 Naproxen for injection is amended in paragraph
(b) by removing ``000033'' and adding in its place ``000856''.
Sec. 522.1940 [Amended]
21. Section 522.1940 Progesterone and estradiol benzoate in
combination is amended in paragraph (b) and (d)(1)(iii) by removing
``000033'' and adding in its place ``000856''.
Sec. 522.2002 [Amended]
22. Section 522.2002 Propiopromazine hydrochloride injection is
amended in paragraph (c) by removing ``000033'' and adding in its place
``000856''.
Sec. 522.2012 [Amended]
23. Section 522.2012 Prostalene solution is amended in paragraph
(b) by removing ``000033'' and adding in its place ``000856''.
Sec. 522.2120 [Amended]
24. Section 522.2120 Spectinomycin injection is amended in
paragraph (b) by removing ``000033'' and adding in its place
``000856''.
Sec. 522.2610 [Amended]
25. Section 522.2610 Trimethoprim and sulfadiazine sterile
suspension is amended in paragraph (a)(2) and (b)(2) by removing
``000033'' and adding in its place ``000856''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
26. 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. 524.660a [Amended]
27. Section 524.660a Dimethyl sulfoxide solution is amended in
paragraph (b) by removing ``000033'' and adding in its place
``000856''.
Sec. 524.660b [Amended]
28. Section 524.660b Dimethyl sulfoxide gel is amended in paragraph
(b) by removing ``000033'' and adding in its place ``000856''.
Sec. 524.960 [Amended]
29. Section 524.960 Flumethasone, neomycin sulfate, and polymyxin B
sulfate ophthalmic solutions is amended in paragraph (b) by removing
``000033'' and adding in its place ``000856''.
Sec. 524.981d [Amended]
30. Section 524.981d Fluocinolone acetonide, dimethyl sulfoxide
solution is amended in paragraph (b) by removing ``000033'' and adding
in its place ``000856''.
Sec. 524.1484e [Amended]
31. Section 524.1484e Neomycin sulfate and polymyxin B sulfate
ophthalmic solution is amended in paragraph (b) by removing ``000033''
and adding in its place ``000856''.
Dated: February 1, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-3078 Filed 2-12-96; 8:45 am]
BILLING CODE 4160-01-F