Last Updated: November 8, 2026

Details for New Drug Application (NDA): 021107

NDA 021107 describes LOTRONEX, which is a drug marketed by Legacy 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 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 021107

Tradename:	LOTRONEX
Applicant:	Legacy
Ingredient:	alosetron hydrochloride
Patents:	0

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	Sebela Pharmaceuticals Inc.	54766-894	54766-894-03	30 TABLET in 1 BOTTLE (54766-894-03)
LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA	Sebela Pharmaceuticals Inc.	54766-895	54766-895-03	30 TABLET in 1 BOTTLE (54766-895-03)

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
Legacy	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	6,284,770	⤷ Start Trial
Legacy	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000	5,360,800	⤷ Start Trial
Legacy	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-002	Dec 23, 2003	5,360,800	⤷ Start Trial
Legacy	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107-001	Feb 9, 2000	6,284,770	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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