Details for New Drug Application (NDA): 218596

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NDA 218596 describes DIROXIMEL FUMARATE, which is a drug marketed by Zydus and is included in one NDA. Additional details are available on the DIROXIMEL FUMARATE profile page.

The generic ingredient in DIROXIMEL FUMARATE is diroximel fumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the diroximel fumarate profile page.

Summary for 218596

Tradename:	DIROXIMEL FUMARATE
Applicant:	Zydus
Ingredient:	diroximel fumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	231MG
Approval Date:	Nov 12, 2025	TE:	AB	RLD:	No

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