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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022246

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NDA 022246 describes METOZOLV ODT, which is a drug marketed by Salix Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the METOZOLV ODT profile page.

The generic ingredient in METOZOLV ODT is metoclopramide hydrochloride. There are twelve drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 022246

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
Approval Date:Sep 4, 2009TE:ABRLD:Yes
Patent:6,413,549Patent Expiration:Jul 11, 2017Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 4, 2009TE:RLD:Yes
Patent:6,413,549Patent Expiration:Jul 11, 2017Product Flag?YSubstance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

McKinsey
Queensland Health
Moodys
Deloitte
Fuji
Mallinckrodt
QuintilesIMS
Argus Health
Novartis
Dow

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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