Regulations.gov document
Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a…
Notice · FDA-2022-N-2390 · posted Mar 7, 2025
Key facts
| Document ID | FDA-2022-N-2390-0161 |
|---|---|
| Title | Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) |
| Document type | Notice |
| Subtype | Notice of Denial |
| Agency | FDA |
| Docket | FDA-2022-N-2390 |
| Posted | Mar 7, 2025 |
| Federal Register citation | 90 FR 11542 |
| FR document number | 2025-03697 |
| Comment period opens | Mar 7, 2025 |
| Effective date | Mar 7, 2025 |
At a glance
- 1–9 Pages
- 1–9 Public comments on this docket
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