Source facts
FDA issued an approval letter for CANAGLIFLOZIN on 2026-06-09. The source metadata identifies ANDA 210449 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CANAGLIFLOZIN — FDA Approval Letter (ANDA 210449)
Issued to APOTEX. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for CANAGLIFLOZIN?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 210449.
- 3Submission: original application.
- 4Sponsor: APOTEX.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CANAGLIFLOZIN approval letter
Is CANAGLIFLOZIN FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 210449 for CANAGLIFLOZIN, sponsored by APOTEX, on June 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 210449?
ANDA 210449 is the application under which FDA issued this approval letter for CANAGLIFLOZIN to APOTEX. The letter is dated June 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.