APPLICATION
ANDA089342
TYPE
ANDA
ORIGINAL APPROVAL
1986-09-16
LATEST ACTION
2021-10-25
ROUTE
INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHOTREXATE SODIUMPrescription
METHOTREXATE SODIUM EQ 200MG BASE/8ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2021-10-25Labeling · Supplement 38 · standardAP
2021-10-25Labeling · Supplement 36 · standardAP
2021-10-25Labeling · Supplement 34 · standardAP
2013-02-05Labeling · Supplement 32AP
2011-04-25Labeling · Supplement 29AP
2001-04-03Manufacturing (CMC) · Supplement 21AP
2000-09-19Labeling · Supplement 20AP
2000-05-24Labeling · Supplement 17AP
1999-11-17Labeling · Supplement 16AP
1999-09-22Labeling · Supplement 15AP
1999-01-28Labeling · Supplement 14AP
1998-06-11Labeling · Supplement 13AP
1995-08-11Manufacturing (CMC) · Supplement 12AP
1995-05-12Manufacturing (CMC) · Supplement 11AP
1993-11-05Manufacturing (CMC) · Supplement 10AP
1993-05-03Manufacturing (CMC) · Supplement 9AP
1993-01-15Manufacturing (CMC) · Supplement 8AP
1990-04-18Labeling · Supplement 7AP
1988-04-25Manufacturing (CMC) · Supplement 3AP
1987-07-20Manufacturing (CMC) · Supplement 1AP
1986-09-16OriginalAP
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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