FDA ANDA · ANDA040263
METHOTREXATE
methotrexate sodium
Sponsor: FRESENIUS KABI USA
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APPLICATION
ANDA040263
TYPE
ANDA
ORIGINAL APPROVAL
1999-02-26
LATEST ACTION
2026-09-30
ROUTE
INTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
METHOTREXATE SODIUMPrescription
METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUMDiscontinued
METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2026-09-30Manufacturing (CMC) · Supplement 24AP
2024-11-29Labeling · Supplement 23 · standardAP
2023-09-15Labeling · Supplement 19 · standardAP
2021-10-27Labeling · Supplement 18 · standardAP
2021-10-27Labeling · Supplement 14 · standardAP
2017-03-07Labeling · Supplement 13 · standardAP
2012-03-29Labeling · Supplement 10AP
2002-12-02Manufacturing (CMC) · Supplement 1AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →