Last Updated: November 8, 2026

Details for New Drug Application (NDA): 200652

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NDA 200652 describes ALOSETRON HYDROCHLORIDE, which is a drug marketed by Adaptis, Amneal Pharms, 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.

Summary for 200652

Tradename:	ALOSETRON HYDROCHLORIDE
Applicant:	Hikma
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:	May 4, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	May 4, 2015	TE:		RLD:	No

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