The list
The list is the list of approved drug products published in FDA's current Approved Drug Products With Therapeutic Equivalence Evaluations, available electronically on FDA's Web site at http://www.fda.gov/cder.
Source
21 CFR § 314.3
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.