Type II active pharmaceutical ingredient drug master file
Defined in 1 place of the United States Code.
The term “Type II active pharmaceutical ingredient drug master file” means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.
Source
- 2012–present21 U.S.C. § 379j-41Food and Drugs · Definitions · for purposes of this subpart