APPLICATION
ANDA081235
TYPE
ANDA
ORIGINAL APPROVAL
1992-05-15
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 36 · standardAP
2021-06-04Labeling · Supplement 30 · standardAP
2019-01-03Labeling · Supplement 29 · standardAP
2014-04-04Labeling · Supplement 19AP
2004-05-11Labeling · Supplement 13AP
2004-02-20Labeling · Supplement 12AP
2002-03-13Manufacturing (CMC) · Supplement 10AP
2002-03-13Manufacturing (CMC) · Supplement 11AP
2000-06-20Labeling · Supplement 9AP
1998-08-31Labeling · Supplement 8AP
1998-06-09Labeling · Supplement 7AP
1998-02-05Manufacturing (CMC) · Supplement 6AP
1995-04-18Manufacturing (CMC) · Supplement 5AP
1994-10-04Labeling · Supplement 2AP
1994-10-04Manufacturing (CMC) · Supplement 1AP
1994-07-29Manufacturing (CMC) · Supplement 4AP
1992-05-15OriginalAP
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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