Source facts
FDA issued an approval letter for ELIQUIS, ELIQUIS SPRINKLE on 2026-06-26. The source metadata identifies NDA 202155, NDA 220073 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ELIQUIS / ELIQUIS SPRINKLE — FDA Approval Letter (NDA 202155)
Issued to BRISTOL MYERS SQUIBB. Application is approved as submitted.
Issued
June 26, 2026Application
NDA 505b1 • 202155
Product
ELIQUIS / ELIQUIS SPRINKLE
Company
BRISTOL MYERS SQUIBB
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ELIQUIS / ELIQUIS SPRINKLE?
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.
- 2Applications: NDA 202155, NDA 220073.
- 3Submission: supplement.
- 4Sponsor: BRISTOL MYERS SQUIBB.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ELIQUIS / ELIQUIS SPRINKLE approval letter
Is ELIQUIS / ELIQUIS SPRINKLE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 202155 for ELIQUIS / ELIQUIS SPRINKLE, sponsored by BRISTOL MYERS SQUIBB, on June 26, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 202155?
NDA 202155 is the application under which FDA issued this approval letter for ELIQUIS / ELIQUIS SPRINKLE to BRISTOL MYERS SQUIBB. The letter is dated June 26, 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.