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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206113

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NDA 206113 describes ALOSETRON HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Hibrow Hlthcare, Hikma, Mankind Pharma, Ph Health, and Rising, and is included in six NDAs. It is available from six suppliers. Additional details are available on the ALOSETRON HYDROCHLORIDE profile page.

The generic ingredient in ALOSETRON HYDROCHLORIDE is alosetron hydrochloride. There are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.

Summary for 206113

Tradename:	ALOSETRON HYDROCHLORIDE
Applicant:	Ph Health
Ingredient:	alosetron hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Feb 23, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Feb 23, 2018	TE:		RLD:	No

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