Source facts
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 209219, ANDA 209271 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
FLUOROURACIL — FDA Approval Letter (ANDA 209219)
Issued to INGENUS PHARMS LLC. Application is approved as submitted.
Issued
March 3, 2026Application
ANDA 505j • 209219
Product
FLUOROURACIL
Company
INGENUS PHARMS LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for FLUOROURACIL?
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.
- 2Applications: ANDA 209219, ANDA 209271.
- 3Submission: supplement.
- 4Sponsor: INGENUS PHARMS LLC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the FLUOROURACIL approval letter
Is FLUOROURACIL FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 209219 for FLUOROURACIL, sponsored by INGENUS PHARMS LLC, 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 209219?
ANDA 209219 is the application under which FDA issued this approval letter for FLUOROURACIL to INGENUS PHARMS LLC. 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.