Guidance: Abbreviated New Drug Application Submissions–Amendments to Abbreviated New Drug Applications Under Generic Drug User Fee Amendments

TitleGuidance: Abbreviated New Drug Application Submissions--Amendments to Abbreviated New Drug Applications Under Generic Drug User Fee Amendments
ToC Doc Abbreviated New Drug Application Submissions--Amendments to Abbreviated New Drug Applications Under Generic Drug User Fee Amendments
Docket Number2022-17414
Type Notice
Subject Guidance:
Abbreviated New Drug Application Submissions--Amendments to Abbreviated New Drug Applications Under Generic Drug User Fee Amendments
Publication Date2022-08-15
Last Updated Date 2022-08-12 08:15:07 -0400
Last Public Inspection2022-08-12
Filed At2022-08-12T08:45:00.000-04:00
PDF 2022-17414_PI.pdf (120992 bytes)
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Number of Pages 5
Filing Typeregular
AgenciesFood and Drug Administration

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