Source facts
FDA issued an approval letter for METHOTREXATE on 2026-03-16. The source metadata identifies NDA 214121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
METHOTREXATE — FDA Approval Letter (NDA 214121)
Issued to ACCORD HLTHCARE. Application is approved as submitted.
Issued
March 16, 2026Application
NDA 505b1 • 214121
Product
METHOTREXATE
Company
ACCORD HLTHCARE
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for METHOTREXATE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 214121.
- 3Submission: supplement.
- 4Sponsor: ACCORD HLTHCARE.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the METHOTREXATE approval letter
Is METHOTREXATE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 214121 for METHOTREXATE, sponsored by ACCORD HLTHCARE, on March 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 214121?
NDA 214121 is the application under which FDA issued this approval letter for METHOTREXATE to ACCORD HLTHCARE. The letter is dated March 16, 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.