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Serving 500+ biopharmaceutical companies globally:

Citi
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Harvard Business School
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Generated: August 19, 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-six 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:► SubscribePatent 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ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:► SubscribePatent Expiration:Jul 11, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022246

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-001Sep 4, 2009► Subscribe► Subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 2009► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Julphar
Farmers Insurance
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UBS
Fuji
AstraZeneca
Boehringer Ingelheim

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