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Not in the current Orange Book— This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

METHOTREXATE SODIUM

ANDANot in Orange Book

METHOTREXATE SODIUM | A089295 | QUAD PHARMS

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

EXCELLA GMBH AND CO KGMETHOTREXATE SODIUM

DMF 124721997

ALEMBIC PHARMACEUTICALS LTDMETHOTREXATE SODIUM

DMF 362772021

MSN LABORATORIES PRIVATE LTDMETHOTREXATE SODIUM

DMF 426272025

SHILPA PHARMA LIFESCIENCES LTDMETHOTREXATE SODIUM

DMF 427952025

BEN VENUE LABORATORIES INCInactiveMETHOTREXATE SODIUM FOR INJECTION, LYOPHILIZED

DMF 61221985

LACHEMA BRNOInactiveMETHOTREXATE SODIUM

DMF 95261992

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — EQ 100MG BASE/VIAL

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.