Docket Number:
None found
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions). The guidance explains that, as of October 1, 2012, under the Generic Drug User Fee Amendments of 2012, commonly referred to as GDUFA:

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All written comments should be identified with this document's docket number: None found.