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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 210226

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NDA 210226 describes DIMETHYL FUMARATE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Torrent, Twi Pharms, and Zydus Pharms, and is included in seventeen NDAs. It is available from eighteen suppliers. Additional details are available on the DIMETHYL FUMARATE profile page.

The generic ingredient in DIMETHYL FUMARATE is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.

Summary for 210226

Tradename:	DIMETHYL FUMARATE
Applicant:	Lupin
Ingredient:	dimethyl fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 210226

Dermatologic Agents
Immunosuppressive Agents
Radiation-Sensitizing Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	120MG
Approval Date:	Oct 5, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	240MG
Approval Date:	Oct 5, 2020	TE:	AB	RLD:	No

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