Source facts
FDA issued an approval letter for ONAPGO on 2026-05-19. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ONAPGO — FDA Approval Letter (NDA 214056)
Issued to MDD US. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for ONAPGO?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 214056.
- 3Submission: supplement.
- 4Sponsor: MDD US.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ONAPGO approval letter
Is ONAPGO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 214056 for ONAPGO, sponsored by MDD US, on May 19, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 214056?
NDA 214056 is the application under which FDA issued this approval letter for ONAPGO to MDD US. The letter is dated May 19, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.