MYTESI (CROFELEMER)
Summary
FDA approved MYTESI (CROFELEMER) by NAPO PHARMS INC. NDA (New Drug) approval (Labeling) on 2024-04-03. TABLET, DELAYED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
NDA202292-9
Action Date
2024-04-03
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
MYTESI (generic: CROFELEMER), TABLET, DELAYED RELEASE, ORAL. Application: NDA202292
Company
Context & Analysis
Frequently Asked Questions
How often does NAPO PHARMS INC have FDA actions?
This is the only FDA action we have on record for NAPO PHARMS INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA202292-9" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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