Source facts
FDA issued an approval letter for VASOPRESSIN on 2026-07-22. The source metadata identifies ANDA 212069 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
VASOPRESSIN — FDA Approval Letter (ANDA 212069)
Issued to SANDOZ. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for VASOPRESSIN?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 212069.
- 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 VASOPRESSIN approval letter
Is VASOPRESSIN FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 212069 for VASOPRESSIN, sponsored by SANDOZ, on July 22, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 212069?
ANDA 212069 is the application under which FDA issued this approval letter for VASOPRESSIN to SANDOZ. The letter is dated July 22, 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.