Last Updated: September 28, 2026

Details for New Drug Application (NDA): 201530

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NDA 201530 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Caplin One Labs, Eugia Pharma Speclts, Extrovis, Hikma, Hospira, Pharmachemie Bv, and Sagent Pharms Inc, 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 is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

Summary for 201530

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date:	Mar 29, 2012	TE:		RLD:	No

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