### Question
How does the law define generic drug submission?


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

> an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application

#### Citation:
  - *21 U.S.C. § 379j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 7-fees relating to generic drugs**

