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FDA ANDA · ANDA090039

METHOTREXATE SODIUM PRESERVATIVE FREE

Sponsor: CAPLIN ONE LABS

APPLICATION
ANDA090039
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-31
LATEST ACTION
2025-01-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

METHOTREXATE SODIUM PRESERVATIVE FREEDiscontinued
METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREEDiscontinued
METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2025-01-31Labeling · Supplement 15 · standardAP
2025-01-31Labeling · Supplement 16 · standardAP
2021-10-25Labeling · Supplement 13 · standardAP
2021-10-25Labeling · Supplement 14 · standardAP
2012-03-30Labeling · Supplement 3AP
2009-03-31OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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