APPLICATION
ANDA040843
TYPE
ANDA
ORIGINAL APPROVAL
2010-01-08
LATEST ACTION
2026-01-14
ROUTE
INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2026-01-14Labeling · Supplement 13 · standardAP
2026-01-14Labeling · Supplement 14 · standardAP
2021-08-02Labeling · Supplement 11 · standardAP
2021-08-02Labeling · Supplement 7 · standardAP
2017-02-24Labeling · Supplement 5 · standardAP
2012-03-30Labeling · Supplement 1AP
2010-01-08OriginalAP
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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