Guidance: Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions under Generic Drug User Fee Amendments

TitleGuidance: Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions under Generic Drug User Fee Amendments
ToC Doc Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions under Generic Drug User Fee Amendments
Docket Number2024-24104
Type Notice
Subject Guidance:
Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions under Generic Drug User Fee Amendments
Publication Date2024-10-18
Last Updated Date 2024-10-17 08:19:19 -0400
Last Public Inspection2024-10-17
Filed At2024-10-17T08:45:00.000-04:00
PDF 2024-24104_PI.pdf (106072 bytes)
Download TXT / HTML / JSON
Number of Pages 6
Filing Typeregular
AgenciesFood and Drug Administration

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