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Federal Trade Commission
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Johnson and Johnson

Generated: December 16, 2017

DrugPatentWatch Database Preview

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 three 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

Therapeutic Class:Gastrointestinal Agents
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

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book Patents for NDA: 021107

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland LtdLOTRONEXalosetron hydrochlorideTABLET;ORAL021107-001Feb 9, 2000► Subscribe► Subscribe
Sebela Ireland LtdLOTRONEXalosetron hydrochlorideTABLET;ORAL021107-002Dec 23, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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