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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 089322

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NDA 089322 describes METHOTREXATE SODIUM, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, Hospira, Norbrook, Pharmachemie Usa, Epic Pharma Llc, Accord Hlthcare, Alembic, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Elite Labs Inc, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Strides Pharma Intl, Sun Pharm, Zydus Pharms, Eugia Pharma Speclts, Extrovis, Pharmachemie Bv, Sagent Pharms Inc, and Sandoz, and is included in thirty-nine NDAs. It is available from twenty-three suppliers. Additional details are available on the METHOTREXATE SODIUM profile page.

The generic ingredient in METHOTREXATE SODIUM is calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

Summary for 089322

Tradename:	METHOTREXATE SODIUM
Applicant:	Abraxis Pharm
Ingredient:	methotrexate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 25MG BASE/ML
Approval Date:	Jun 13, 1986	TE:		RLD:	No

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