authorized generic drug

(3)In this section, the term “authorized generic drug” means a listed drug (as that term is used in subsection (j)) that— (A)has been approved under subsection (c); and (B)is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed drug. (u)


21 USC § 355(t)()(3)

Scoping language

In this section
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