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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 213522

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NDA 213522 describes ELUXADOLINE, which is a drug marketed by Zydus Pharms and is included in one NDA. Additional details are available on the ELUXADOLINE profile page.

The generic ingredient in ELUXADOLINE is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.

Summary for 213522

Tradename:	ELUXADOLINE
Applicant:	Zydus Pharms
Ingredient:	eluxadoline
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Mar 14, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 14, 2025	TE:		RLD:	No

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