### Question
What does substantially complete application mean?


### Answer
**Substantially complete application** has the following meaning in *21 U.S.C. § 355*:

> an application under this subsection that on its face is sufficiently complete to permit a substantive review and contains all the information required by paragraph (2)(A)

#### Citation:
  - *21 U.S.C. § 355*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

