Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!


New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

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

Start Preamble


Food and Drug Administration, HHS.


Notification of withdrawal.


The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.


Withdrawal of approval is effective April 9, 2018.

Start Further Info


Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761,

End Further Info End Preamble Start Supplemental Information


During July and August 2017, the following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:

File No.SponsorProduct name21 CFR section
047-055Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880Chorionic Gonadotropin Powder for Injection522.1081
Start Printed Page 13638
104-606Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880Dexamethasone Sodium Phosphate Injection522.540
139-633Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550WILDNIL (carfentanil citrate) Injection522.300

Therefore, under authority delegated to the Commissioner of Food and Drugs, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is hereby withdrawn, effective April 9, 2018.

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.

Start Signature

Dated: March 21, 2018.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2018-06357 Filed 3-29-18; 8:45 am]