### Question
How is the "generic drug submission" defined?


### Answer
The term **generic drug submission** is defined in *21 U.S.C. § 379j* as follows -

> 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**

