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FDA ANDA · ANDA040767

METHOTREXATE SODIUM PRESERVATIVE FREE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA040767
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-30
LATEST ACTION
2025-01-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METHOTREXATE SODIUM PRESERVATIVE FREEPrescription
METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2025-01-14Labeling · Supplement 12 · standardAP
2025-01-14Labeling · Supplement 13 · standardAP
2023-08-16Labeling · Supplement 10 · standardAP
2021-06-07Labeling · Supplement 8 · standardAP
2012-03-16Labeling · Supplement 4AP
2007-04-30OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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