AB-rated Generic Version definition
AB-rated Generic Version means an ANDA found by the FDA to be bioequivalent to the Referenced Drug Product, as defined under 21 U.S.C. § 355(j)(8)(B).
AB-rated Generic Version means an ANDA found by the Food and Drug Administration to be bioequivalent to the Referenced Drug Product, as defined under 21 U.S.C. § 355(j)(8)(B) (2003).