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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213362

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NDA 213362 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, Sun Pharm, Zydus Pharms, Eugia Pharma Speclts, Pharmachemie Bv, Rising, Sagent Pharms Inc, and Sandoz, and is included in thirty-nine NDAs. It is available from twenty-four 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 213362

Tradename:	METHOTREXATE SODIUM
Applicant:	Daito
Ingredient:	methotrexate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Aug 7, 2023	TE:	AB	RLD:	No

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