Source facts
FDA issued an approval letter for DIPRIVAN on 2026-02-19. The source metadata identifies NDA 019627 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DIPRIVAN — FDA Approval Letter (NDA 019627)
Issued to FRESENIUS KABI USA. Application is approved as submitted.
Issued
February 19, 2026Application
NDA 505b1 • 019627
Product
DIPRIVAN
Company
FRESENIUS KABI USA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DIPRIVAN?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 019627.
- 3Submission: supplement.
- 4Sponsor: FRESENIUS KABI USA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DIPRIVAN approval letter
Is DIPRIVAN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 019627 for DIPRIVAN, sponsored by FRESENIUS KABI USA, on February 19, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 019627?
NDA 019627 is the application under which FDA issued this approval letter for DIPRIVAN to FRESENIUS KABI USA. The letter is dated February 19, 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.