Source facts
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 040333, ANDA 040334 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 040333)
Issued to TEVA PHARMS USA. Application is approved as submitted.
Issued
March 3, 2026Application
ANDA 505j • 040333
Product
FLUOROURACIL
Company
TEVA PHARMS USA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for FLUOROURACIL?
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Key details in this letter
- 1FDA action: approval.
- 2Applications: ANDA 040333, ANDA 040334.
- 3Submission: supplement.
- 4Sponsor: TEVA PHARMS USA.
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 040333 for FLUOROURACIL, sponsored by TEVA PHARMS USA, 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 040333?
ANDA 040333 is the application under which FDA issued this approval letter for FLUOROURACIL to TEVA PHARMS USA. 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.