innovator multiple source drug
Defined in 1 dictionary — U.S. Code
United States Code
42 U.S.C. § 1395L — under this part (26 versions over time)
The term “innovator multiple source drug” has the meaning given such term in section 1396r–8(k)(7)(A)(ii) of this title.
42 U.S.C. § 1396R — under this subchapter (2 versions over time)
The term “innovator multiple source drug” means a multiple source drug that is marketed under a new drug application approved by the Food and Drug Administration, unless the Secretary determines that a narrow exception applies (as described in section 447.502 of title 42, Code of Federal Regulations (or any successor regulation)).