Source facts
FDA issued an approval letter for CALCITRIOL on 2026-03-03. The source metadata identifies ANDA 219796 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CALCITRIOL — FDA Approval Letter (ANDA 219796)
Issued to HUMANWELL PURACAP. Application is approved as submitted.
Issued
March 3, 2026Application
ANDA 505j • 219796
Product
CALCITRIOL
Company
HUMANWELL PURACAP
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CALCITRIOL?
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.
- 2Application: ANDA 219796.
- 3Submission: original application.
- 4Sponsor: HUMANWELL PURACAP.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CALCITRIOL approval letter
Is CALCITRIOL FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 219796 for CALCITRIOL, sponsored by HUMANWELL PURACAP, on March 3, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 219796?
ANDA 219796 is the application under which FDA issued this approval letter for CALCITRIOL to HUMANWELL PURACAP. The letter is dated March 3, 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.