APPLICATION
ANDA213343
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-24
LATEST ACTION
2026-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHOTREXATE SODIUMPrescription
METHOTREXATE SODIUM EQ 2.5MG BASE · TABLET · ORAL
Approval history
2026-05-27Labeling · Supplement 4 · standardAP
2021-11-08Labeling · Supplement 1 · standardAP
2020-01-24UNKNOWN · Original · standardAP
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.