APPLICATION
ANDA201530
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-29
LATEST ACTION
2021-07-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METHOTREXATE SODIUM PRESERVATIVE FREEDiscontinued
METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2021-07-13Labeling · Supplement 8 · standardAP
2021-07-13Labeling · Supplement 6 · standardAP
2015-10-05Labeling · Supplement 3 · standardAP
2012-03-29Not Applicable · OriginalAP
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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