TPOXX (TECOVIRIMAT MONOHYDRATE)
Summary
FDA approved TPOXX (TECOVIRIMAT MONOHYDRATE) by SIGA TECHNOLOGIES. NDA (New Drug) approval (Labeling) on 2024-06-03. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA208627-8
Action Date
2024-06-03
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
TPOXX (generic: TECOVIRIMAT MONOHYDRATE), CAPSULE, ORAL. Application: NDA208627
Company
Context & Analysis
Frequently Asked Questions
How often does SIGA TECHNOLOGIES have FDA actions?
This is the only FDA action we have on record for SIGA TECHNOLOGIES in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA208627-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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