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FDA ANDA · ANDA040054

METHOTREXATE SODIUM

Sponsor: HIKMA

APPLICATION
ANDA040054
TYPE
ANDA
ORIGINAL APPROVAL
1994-08-01
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 19 · standardAP
2020-10-29Labeling · Supplement 16 · standard — Letter ↗AP
2020-10-29Labeling · Supplement 17 · standard — Letter ↗AP
2020-10-29Labeling · Supplement 15 · standard — Letter ↗AP
2007-11-26Labeling · Supplement 5AP
2006-09-13Labeling · Supplement 4AP
2001-10-30Labeling · Supplement 3AP
1998-05-07Labeling · Supplement 2AP
1994-11-10Labeling · Supplement 1AP
1994-08-01OriginalAP
VIEW ON DRUGS@FDA ↗

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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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