### Question
How does FEDERAL FOOD, DRUG, AND COSMETIC ACT define generic new animal drug product?


### Answer
Under *21 U.S.C. § 379j*, **generic new animal drug product** is defined as:

> each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 5-fees relating to generic new animal drugs**

