APPLICATION
ANDA201749
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-21
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 11 · standardAP
2021-11-08Labeling · Supplement 6 · standardAP
2021-11-08Labeling · Supplement 10 · standardAP
2021-11-08Labeling · Supplement 3 · standardAP
2015-05-21Not Applicable · OriginalAP
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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