Methotrexate

NDA 214121, held by Accord Hlthcare. Methotrexate.

As of Nov 13, 2026, NDA 214121 (Methotrexate), held by Accord Hlthcare, was first approved by FDA on Aug 24, 2020, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 24, 2020
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Mar 10, 2022	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 24, 2020	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methotrexate5GM/50ML (100MG/ML) · solution;intravenous	Methotrexate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Oct 15, 2026	Supplement 6Labeling · Standard review	Approved	Label Letter
Mar 13, 2026	Supplement 5Labeling · Standard review	Approved	Letter Label
May 29, 2025	Supplement 4Labeling · Standard review	Approved	Letter
Sep 12, 2024	Supplement 3Labeling · Standard review	Approved	Letter Label
Mar 10, 2022	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 24, 2020	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter

Identifiers

Application: NDA 214121
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters