APPLICATION
ANDA040265
TYPE
ANDA
ORIGINAL APPROVAL
1999-02-26
LATEST ACTION
2017-03-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METHOTREXATE PRESERVATIVE FREEDiscontinued
METHOTREXATE SODIUM EQ 25MG BASE/ML · INJECTABLE · INJECTION
Approval history
2017-03-03Labeling · Supplement 14 · standardAP
2002-12-02Manufacturing (CMC) · Supplement 6AP
2001-10-16Labeling · Supplement 5AP
2001-10-16Manufacturing (CMC) · Supplement 3AP
2001-10-16Manufacturing (CMC) · Supplement 4AP
2001-10-16Manufacturing (CMC) · Supplement 2AP
2000-02-17Manufacturing (CMC) · Supplement 1AP
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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