innovator multiple source drug
Defined in 2 places of the United States Code.
The term “innovator multiple source drug” has the meaning given such term in section 1396r–8(k)(7)(A)(ii) of this title.
Source
- 2003–present42 U.S.C. § 1395LThe Public Health and Welfare · Payment of benefits · under this part
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)).
Source
- 2019–present42 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter
The term “innovator multiple source drug” means a multiple source drug that was originally marketed under an original new drug application approved by the Food and Drug Administration.
Source
- 1994–201942 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter