[Federal Register Volume 59, Number 26 (Tuesday, February 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2754]


[[Page Unknown]]

[Federal Register: February 8, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 524

 

Animal Drugs, Feeds, and Related Products; Promazine 
Hydrochloride Tablets; Nitrofurazone Solution

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 remove those portions of the regulations that 
reflect approval of two new animal drug applications (NADA's). One NADA 
is held by Wyeth-Ayerst Laboratories and provides for use of promazine 
hydrochloride tablets. The other NADA is held by Squire Laboratories, 
Inc., and provides for use of nitrofurazone solution. In a notice 
published elsewhere in this issue of the Federal Register, FDA is 
withdrawing approval of the NADA's.

EFFECTIVE DATE: February 18, 1994.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0749.

SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of NADA 10-
783 for Sparine Tablets (promazine hydrochloride) held by Wyeth-Ayerst 
Laboratories, Division of American Home Products Corp., P.O. Box 8299, 
Philadelphia, PA 19101, and NADA 138-455 for Fura-Zone Solution 
(nitrofurazone) held by Squire Laboratories, Inc., 100 Mill St., 
Revere, MA 02151. The sponsors requested withdrawal of approval of the 
NADA's. This document removes 21 CFR 520.1962(b) and amends 21 CFR 
524.1580d(b) to reflect the withdrawal of approval of these NADA's.

List of Subjects in 21 CFR Parts 520 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 520 and 
524 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. 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. 520.1962  [Amended]

    2. Section 520.1962 Promazine hydrochloride is amended by removing 
paragraph (b) and reserving it.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    3. 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. 524.1580d  [Amended]

    4. Section 524.1580d Nitrofurazone solution is amended in paragraph 
(b) by removing the last sentence.

    Dated: January 31, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-2754 Filed 2-7-94; 8:45 am]
BILLING CODE 4160-01-F