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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090039

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NDA 090039 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma Speclts, Extrovis, Hikma, Hospira, Pharmachemie Bv, Sagent Pharms Inc, and Sandoz, and is included in thirteen NDAs. It is available from five suppliers. Additional details are available on the METHOTREXATE SODIUM PRESERVATIVE FREE profile page.

The generic ingredient in METHOTREXATE SODIUM PRESERVATIVE FREE is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for 090039

Tradename:	METHOTREXATE SODIUM PRESERVATIVE FREE
Applicant:	Sandoz
Ingredient:	methotrexate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date:	Mar 31, 2009	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Approval Date:	Mar 31, 2009	TE:	AP	RLD:	No

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