Source facts
FDA issued an approval letter for METHOTREXATE SODIUM on 2026-05-29. The source metadata identifies NDA 008085 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
METHOTREXATE SODIUM — FDA Approval Letter (NDA 008085)
Issued to STRIDES PHARMA INTL. Application is approved as submitted.
Issued
May 29, 2026Application
NDA 505b1 • 008085
Product
METHOTREXATE SODIUM
Company
STRIDES PHARMA INTL
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for METHOTREXATE SODIUM?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 008085.
- 3Submission: supplement.
- 4Sponsor: STRIDES PHARMA INTL.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the METHOTREXATE SODIUM approval letter
Is METHOTREXATE SODIUM FDA approved?
This letter documents an FDA approval action: FDA approved NDA 008085 for METHOTREXATE SODIUM, sponsored by STRIDES PHARMA INTL, on May 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 008085?
NDA 008085 is the application under which FDA issued this approval letter for METHOTREXATE SODIUM to STRIDES PHARMA INTL. The letter is dated May 29, 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.