Last Updated: November 8, 2026

Details for New Drug Application (NDA): 210531

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NDA 210531 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, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Torrent, Twi Pharms, and Zydus Pharms, and is included in seventeen NDAs. It is available from nineteen suppliers. Additional details are available on the DIMETHYL FUMARATE profile page.

The generic ingredient in DIMETHYL FUMARATE is dimethyl fumarate. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.

Summary for 210531

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

Medical Subject Heading (MeSH) Categories for 210531

Dermatologic Agents
Immunosuppressive Agents
Radiation-Sensitizing Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	120MG
Approval Date:	Aug 17, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	240MG
Approval Date:	Aug 17, 2020	TE:		RLD:	No

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