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FDA ANDA · ANDA203407
METHOTREXATE SODIUM PRESERVATIVE FREE
Sponsor: SAGENT PHARMS INC
APPLICATION
ANDA203407
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-09
LATEST ACTION
2021-08-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 1GM BASE/40ML (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
Approval history
2021-08-17Labeling · Supplement 1 · standardAP
2018-08-09UNKNOWN · 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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