APPLICATION
ANDA201529
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-29
LATEST ACTION
2021-07-19
ROUTE
INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 200MG BASE/8ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
Approval history
2021-07-19Labeling · Supplement 7 · standardAP
2021-07-19Labeling · Supplement 10 · standardAP
2015-10-05Labeling · Supplement 4 · 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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