Source facts
FDA issued an approval letter for NUCYNTA ER on 2026-06-23. The source metadata identifies NDA 200533 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
NUCYNTA ER — FDA Approval Letter (NDA 200533)
Issued to COLLEGIUM PHARM INC. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 200533
Product
NUCYNTA ER
Company
COLLEGIUM PHARM INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for NUCYNTA ER?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 200533.
- 3Submission: supplement.
- 4Sponsor: COLLEGIUM PHARM INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the NUCYNTA ER approval letter
Is NUCYNTA ER FDA approved?
This letter documents an FDA approval action: FDA approved NDA 200533 for NUCYNTA ER, sponsored by COLLEGIUM PHARM INC, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 200533?
NDA 200533 is the application under which FDA issued this approval letter for NUCYNTA ER to COLLEGIUM PHARM INC. The letter is dated June 23, 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.