← FDA DRUG APPROVALS

FDA NDA · NDA008085

METHOTREXATE SODIUM

Sponsor: STRIDES PHARMA INTL

APPLICATION
NDA008085
TYPE
NDA
ORIGINAL APPROVAL
1953-12-07
LATEST ACTION
2026-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHOTREXATE SODIUM · ReferenceDiscontinued
METHOTREXATE SODIUM EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2026-05-27Labeling · Supplement 72 · standard — Letter ↗AP
2020-05-04Efficacy · Supplement 71 · standard — Label ↗AP
2019-08-16Manufacturing (CMC) · Supplement 63AP
2018-03-15Labeling · Supplement 68 · 901 required — Label ↗AP
2016-01-29Labeling · Supplement 66 · standard — Letter ↗AP
2015-12-02Manufacturing (CMC) · Supplement 65 · priorityAP
2006-05-31Labeling · Supplement 58 · standard — Letter ↗AP
2003-10-24Labeling · Supplement 52 · standard — Letter ↗AP
2003-10-24Manufacturing (CMC) · Supplement 55 · priority — Letter ↗AP
2002-02-20Labeling · Supplement 53 · priority — Letter ↗AP
2002-02-20Labeling · Supplement 54 · standard — Letter ↗AP
2001-05-08Labeling · Supplement 51 · standardAP
2000-11-08Labeling · Supplement 46 · standardAP
2000-02-09Manufacturing (CMC) · Supplement 50 · priorityAP
1999-10-29Labeling · Supplement 48 · standardAP
1998-06-18Manufacturing (CMC) · Supplement 47 · priorityAP
1997-05-20Labeling · Supplement 45 · standardAP
1991-07-24Labeling · Supplement 39AP
1990-10-24Manufacturing (CMC) · Supplement 38 · priorityAP
1990-10-05Manufacturing (CMC) · Supplement 40 · priorityAP
1990-01-18Labeling · Supplement 32AP
1989-11-16Manufacturing (CMC) · Supplement 34 · priorityAP
1989-05-18Manufacturing (CMC) · Supplement 36 · priorityAP
1989-04-24Labeling · Supplement 35AP
1988-10-31Manufacturing (CMC) · Supplement 27 · priorityAP
1988-10-31Efficacy · Supplement 28AP
1986-12-08Manufacturing (CMC) · Supplement 31 · priorityAP
1986-09-16Labeling · Supplement 30AP
1984-07-19Manufacturing (CMC) · Supplement 24 · priorityAP
1984-04-04Manufacturing (CMC) · Supplement 23 · priorityAP
1983-08-04Manufacturing (CMC) · Supplement 21 · priorityAP
1983-02-04Manufacturing (CMC) · Supplement 19 · priorityAP
1979-09-05Manufacturing (CMC) · Supplement 17 · priorityAP
1979-05-01Manufacturing (CMC) · Supplement 15 · priorityAP
1978-07-10Manufacturing (CMC) · Supplement 16 · priorityAP
1977-04-29Manufacturing (CMC) · Supplement 13 · priorityAP
1977-04-29Labeling · Supplement 14AP
1976-01-26Supplement · Supplement 11 · priorityAP
1953-12-07Type 1 - New Molecular Entity · Original · priorityAP
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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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