Details for New Drug Application (NDA): 021107

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NDA 021107 describes LOTRONEX, which is a drug marketed by Sebela Ireland Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the LOTRONEX profile page.

The generic ingredient in LOTRONEX 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 021107

Tradename:	LOTRONEX
Applicant:	Sebela Ireland Ltd
Ingredient:	alosetron hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021107

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 021107

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	45963-479	45963-479-03	1 BOTTLE in 1 CARTON (45963-479-03) / 30 TABLET in 1 BOTTLE
LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	45963-480	45963-480-03	1 BOTTLE in 1 CARTON (45963-480-03) / 30 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Feb 9, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Dec 23, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021107

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	See Plans and Pricing	See Plans and Pricing
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	See Plans and Pricing	See Plans and Pricing
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000	See Plans and Pricing	See Plans and Pricing
Sebela Ireland Ltd	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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