Source facts
FDA issued an approval letter for QUILLIVANT XR on 2026-03-10. The source metadata identifies NDA 202100 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
QUILLIVANT XR — FDA Approval Letter (NDA 202100)
Issued to NEXTWAVE. Application is approved as submitted.
Issued
March 10, 2026Application
NDA 505b1 • 202100
Product
QUILLIVANT XR
Company
NEXTWAVE
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for QUILLIVANT 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 202100.
- 3Submission: supplement.
- 4Sponsor: NEXTWAVE.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the QUILLIVANT XR approval letter
Is QUILLIVANT XR FDA approved?
This letter documents an FDA approval action: FDA approved NDA 202100 for QUILLIVANT XR, sponsored by NEXTWAVE, on March 10, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 202100?
NDA 202100 is the application under which FDA issued this approval letter for QUILLIVANT XR to NEXTWAVE. The letter is dated March 10, 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.