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Withdrawal of Approval of New Animal Drug Applications; Roxarsone

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.


Notice of withdrawal.


The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's request because the products are no longer manufactured or marketed.


Withdrawal of approval is effective January 6, 2014.

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John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079,

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Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of the following five NADAs for roxarsone oral dosage form products, used to make medicated drinking water for chickens, turkeys, and swine, because the products are no longer manufactured or marketed:

NADAProprietary name
005-414REN-O-SAL Tablets.
006-019Zuco Poultry Tablets.
006-081Korum Improved Formula.
008-274Pig Scour Tablets.
093-0253-NITRO Soluble.

Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 005-414, 006-019, 006-081, 008-274, and 093-025, and all supplements and amendments thereto, is hereby withdrawn, effective January 6, 2014.

Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.

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Dated: December 20, 2013.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. 2013-30837 Filed 12-26-13; 8:45 am]