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In this section: Generic Drug User Fee Amendments

Self-Identification of Generic Drug Facilities, Sites and Organizations

Fiscal year 2018 reporting period for self-identification opens May 1st to June 1st of 2017

Generic Drug Facilities, Sites and Organization Lists
GDUFA Self-Identification (SPL) Submission – Part 1
GDUFA Self-Identification (SPL) Submission – Part 2
Self-Identified Frequently Asked Questions

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