APPLICATION
ANDA210454
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-30
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 5 · standardAP
2020-08-26Labeling · Supplement 2 · standardAP
2020-08-26Labeling · Supplement 1 · standardAP
2020-01-30UNKNOWN · 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.
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