Source facts
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 203608, ANDA 203609 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 203608)
Issued to SAGENT PHARMS INC. Application is approved as submitted.
Issued
March 3, 2026Application
ANDA 505j • 203608
Product
FLUOROURACIL
Company
SAGENT PHARMS INC
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 203608, ANDA 203609.
- 3Submission: supplement.
- 4Sponsor: SAGENT PHARMS INC.
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 203608 for FLUOROURACIL, sponsored by SAGENT PHARMS INC, 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 203608?
ANDA 203608 is the application under which FDA issued this approval letter for FLUOROURACIL to SAGENT PHARMS INC. 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.