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Last Updated: December 22, 2024

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 Ltd, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Twi Pharms, and Zydus Pharms, and is included in sixteen 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 are seventy-six drug master file entries 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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