All regulations
Nonrulemaking
FDA
FDA-2022-N-2390
Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing
Documents
676
Comments
0
Key Dates
Comment Period OpensOct 11, 2022
Comment Period ClosesJul 7, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
Proposal To Refuse To Approve a New Drug
Application Supplement for Hetlioz
(Tasimelteon); Opportunity for a Hearing
Notice
CDER
2022-536
Open
Data from Regulations.gov