Details for New Drug Application (NDA): 206647

NDA 206647 describes ALOSETRON HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Endo Operations, Hibrow Hlthcare, Hikma, Mankind Pharma, and Rising, and is included in six NDAs. It is available from four 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. Six suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.

Summary for 206647

Tradename:	ALOSETRON HYDROCHLORIDE
Applicant:	Amneal Pharms
Ingredient:	alosetron hydrochloride
Patents:	0

Pharmacology for NDA: 206647

Mechanism of Action

Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 206647

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	206647	ANDA	Amneal Pharmaceuticals of New York LLC	53746-248	53746-248-30	30 TABLET, FILM COATED in 1 BOTTLE (53746-248-30)
ALOSETRON HYDROCHLORIDE	alosetron hydrochloride	TABLET;ORAL	206647	ANDA	Amneal Pharmaceuticals of New York LLC	53746-249	53746-249-30	30 TABLET, FILM COATED in 1 BOTTLE (53746-249-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Dec 22, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Dec 22, 2016	TE:	AB	RLD:	No

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