Last Updated: September 24, 2026

Details for New Drug Application (NDA): 210285

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NDA 210285 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 210285

Tradename:	DIMETHYL FUMARATE
Applicant:	Sawai Usa
Ingredient:	dimethyl fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 210285

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:	Dec 21, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	240MG
Approval Date:	Dec 21, 2021	TE:		RLD:	No

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