Proposal to Refuse To Approve a New Drug Application Supplement: Hetlioz (Tasimelteon)

TitleProposal to Refuse To Approve a New Drug Application Supplement: Hetlioz (Tasimelteon)
ToC Doc Hetlioz (Tasimelteon)
Docket Number2024-12564
Type Notice
Subject Proposal to Refuse To Approve a New Drug Application Supplement:
Hetlioz (Tasimelteon)
Publication Date2024-06-07
Last Updated Date 2024-06-06 08:21:29 -0400
Last Public Inspection2024-06-06
Filed At2024-06-06T08:45:00.000-04:00
PDF 2024-12564_PI.pdf (116042 bytes)
Download TXT / HTML / JSON
Number of Pages 8
Filing Typeregular
AgenciesFood and Drug Administration

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