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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071250

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NDA 071250 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Morton Grove, Paco, Pharm Assoc, Roxane, Silarx, Teva, Vistapharm, Wockhardt Bio Ag, Novel Labs Inc, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Par Pharm Inc, Sandoz, Schering, Sun Pharm Industries, Superpharm, Usl Pharma, Vintage Pharms, Watson Labs, and Yaopharma Co Ltd, and is included in fifty-three NDAs. It is available from forty-two suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are twelve drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 071250
Tradename:METOCLOPRAMIDE HYDROCHLORIDE
Applicant:Impax Labs Inc
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071250
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 071250
Suppliers and Packaging for NDA: 071250
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 071250 ANDA Impax Generics 0115-1651 N 0115-1651-01
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 071250 ANDA Impax Generics 0115-1651 N 0115-1651-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 3, 1988TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Dec 28, 1995TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
McKinsey
McKesson
Cantor Fitzgerald
QuintilesIMS
Johnson and Johnson
Queensland Health
Covington
Deloitte

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