Substantially complete application

Substantially complete application is an ANDA that on its face is sufficiently complete to permit a substantive review. Sufficiently complete means that the ANDA contains all the information required under section 505(2)(A) of the Federal Food, Drug, and Cosmetic Act and does not contain a deficiency described in 314.101(d) and (e).

Source

21 CFR § 314.3

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Scoping language

The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter.

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