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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 211621

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NDA 211621 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 211621

Tradename:	ALOSETRON HYDROCHLORIDE
Applicant:	Hibrow Hlthcare
Ingredient:	alosetron hydrochloride
Patents:	0

Pharmacology for NDA: 211621

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 211621

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	211621	ANDA	Eywa Pharma Inc	71930-010	71930-010-30	30 TABLET in 1 BOTTLE (71930-010-30)
ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	211621	ANDA	Eywa Pharma Inc	71930-011	71930-011-30	30 TABLET in 1 BOTTLE (71930-011-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Sep 16, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Sep 16, 2019	TE:	AB	RLD:	No

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