FDA NDA · NDA214121

METHOTREXATE

Sponsor: ACCORD HLTHCARE

What this page does not claim

A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.

APPLICATION
NDA214121
TYPE
NDA
ORIGINAL APPROVAL
2020-08-24
LATEST ACTION
2026-10-15
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

METHOTREXATE · ReferenceDiscontinued
METHOTREXATE 5GM/50ML (100MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-10-15Labeling · Supplement 6 · standard — Letter ↗AP
2026-03-13Labeling · Supplement 5 · standard — Letter ↗AP
2025-05-29Labeling · Supplement 4 · standard — Letter ↗AP
2024-09-12Labeling · Supplement 3 · standard — Label ↗AP
2022-03-10Efficacy · Supplement 1 · standard — Letter ↗AP
2020-08-24Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP