Source facts
FDA issued an approval letter for ENZALUTAMIDE on 2026-06-09. The source metadata identifies ANDA 216068 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ENZALUTAMIDE — FDA Approval Letter (ANDA 216068)
Issued to SANDOZ. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for ENZALUTAMIDE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 216068.
- 3Submission: original application.
- 4Sponsor: SANDOZ.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ENZALUTAMIDE approval letter
Is ENZALUTAMIDE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 216068 for ENZALUTAMIDE, sponsored by SANDOZ, 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 216068?
ANDA 216068 is the application under which FDA issued this approval letter for ENZALUTAMIDE to SANDOZ. 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.