.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022246

« Back to Dashboard
NDA 022246 describes METOZOLV ODT, which is a drug marketed by Salix Pharms and is included in one NDA. It is available from one supplier. 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. Fifty-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 022246

Tradename:
METOZOLV ODT
Applicant:
Salix Pharms
Ingredient:
metoclopramide hydrochloride
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 022246

Mechanism of ActionDopamine D2 Antagonists

Suppliers and Packaging for NDA: 022246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL 022246 NDA Salix Pharmaceuticals, Inc. 65649-431 65649-431-02 10 BLISTER PACK in 1 CARTON (65649-431-02) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL 022246 NDA Salix Pharmaceuticals, Inc. 65649-432 65649-432-02 10 BLISTER PACK in 1 CARTON (65649-432-02) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:6,413,549Patent Expiration:Jul 11, 2017Product Flag?YSubstance Flag?Delist Request?


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc