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U.S. Department of Health and Human Services

Animal & Veterinary

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Revised 356v Form Available

February 1, 1999

The form for submitting a New Animal Drug Application (NADA) has been revised.

The form, FDA 356v, reflects the instructions for preparing and submitting a new animal drug application (drug products for animal use) as described in Title 21, Part 514 of the Code of Federal Regulations. The form is used for submitting original New Animal Drug Applications, Abbreviated New Animal Drug Applications, as well as Supplemental New Animal Drug Applications to FDA's Center for Veterinary Medicine (CVM).

The revised form has an expiration date of July 31, 2001. Drug sponsors should discard previous versions of Form FDA 356v and use the revised version. For applications already in the "pipeline," previous versions of the Form FDA 356v are still acceptable.

Copies of the revised form are available on the CVM's Internet Home Page. A copy of this form may also be obtained by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Send one self-addressed adhesive label to assist in processing your requests.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855