APPLICATION
ANDA040632
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-12
LATEST ACTION
2025-08-18
ROUTE
INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-08-18Labeling · Supplement 11 · standardAP
2025-08-18Labeling · Supplement 16 · standardAP
2013-02-05Labeling · Supplement 6AP
2011-03-08Labeling · Supplement 4AP
2005-08-12OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.