Source facts
FDA issued an approval letter for RIVAROXABAN on 2026-07-06. The source metadata identifies ANDA 208334 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
RIVAROXABAN — FDA Approval Letter (ANDA 208334)
Issued to MICRO LABS. Application is approved as submitted.
Issued
July 6, 2026Application
ANDA 505j • 208334
Product
RIVAROXABAN
Company
MICRO LABS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for RIVAROXABAN?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 208334.
- 3Submission: original application.
- 4Sponsor: MICRO LABS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the RIVAROXABAN approval letter
Is RIVAROXABAN FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 208334 for RIVAROXABAN, sponsored by MICRO LABS, on July 6, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 208334?
ANDA 208334 is the application under which FDA issued this approval letter for RIVAROXABAN to MICRO LABS. The letter is dated July 6, 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.