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Generated: November 16, 2018

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. Additional details are available on the METOZOLV ODT profile page.

The generic ingredient in METOZOLV ODT is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 022246
Tradename:METOZOLV ODT
Applicant:Salix Pharms
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022246

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
Approval Date:Sep 4, 2009TE:RLD:Yes

Profile 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ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Expired US 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;ORAL 022246-001 Sep 4, 2009 ➤ Sign Up ➤ Sign Up
Salix Pharms METOZOLV ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022246-002 Sep 4, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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