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FDA NDA · NDA214121

METHOTREXATE

Sponsor: ACCORD HLTHCARE

APPLICATION
NDA214121
TYPE
NDA
ORIGINAL APPROVAL
2020-08-24
LATEST ACTION
2026-03-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

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

Approval history

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
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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