APPLICATION
ANDA040266
TYPE
ANDA
ORIGINAL APPROVAL
1999-02-26
LATEST ACTION
2024-08-27
ROUTE
INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHOTREXATE PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-08-27Labeling · Supplement 22 · standardAP
2023-09-18Labeling · Supplement 17 · standardAP
2021-09-14Labeling · Supplement 16 · standardAP
2021-09-14Labeling · Supplement 12 · standardAP
2017-03-03Labeling · Supplement 11 · standardAP
2012-09-28Labeling · Supplement 7AP
2000-01-24Manufacturing (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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