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Last Updated: July 3, 2020

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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. Six 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
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 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 Actavis Pharma, Inc. 45963-480 45963-480-03 1 BOTTLE in 1 CARTON (45963-480-03) > 30 TABLET in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021107
Tradename Dosage Ingredient NDA Submissiondate
LOTRONEX TABLET;ORAL alosetron hydrochloride 021107 2010-12-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Feb 9, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:Dec 23, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021107

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

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