Source facts
FDA issued an approval letter for QUDEXY XR on 2026-03-09. The source metadata identifies NDA 205122 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
QUDEXY XR — FDA Approval Letter (NDA 205122)
Issued to UPSHER SMITH LABS. Application is approved as submitted.
Issued
March 9, 2026Application
NDA 505b1 • 205122
Product
QUDEXY XR
Company
UPSHER SMITH LABS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for QUDEXY XR?
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 205122.
- 3Submission: supplement.
- 4Sponsor: UPSHER SMITH LABS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the QUDEXY XR approval letter
Is QUDEXY XR FDA approved?
This letter documents an FDA approval action: FDA approved NDA 205122 for QUDEXY XR, sponsored by UPSHER SMITH LABS, on March 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 205122?
NDA 205122 is the application under which FDA issued this approval letter for QUDEXY XR to UPSHER SMITH LABS. The letter is dated March 9, 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.