← FDA DRUG APPROVALS

FDA NDA · NDA208400

XATMEP

methotrexate

Sponsor: AZURITY

APPLICATION
NDA208400
TYPE
NDA
ORIGINAL APPROVAL
2017-04-25
LATEST ACTION
2026-05-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XATMEP · ReferencePrescription
METHOTREXATE SODIUM EQ 2.5MG BASE/ML · SOLUTION · ORAL

Approval history

2026-05-27Labeling · Supplement 5 · standard — Letter ↗AP
2018-03-15Labeling · Supplement 2 · 901 required — Label ↗AP
2017-04-25Type 3 - New Dosage Form · Original · standard — Label ↗AP
2017-04-25Efficacy · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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