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QuintilesIMS
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Fish and Richardson

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070581

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NDA 070581 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, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Roxane, 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 070581
Tradename:METOCLOPRAMIDE HYDROCHLORIDE
Applicant:Par Pharm Inc
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070581
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 070581
Suppliers and Packaging for NDA: 070581
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070581 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2536 N 0615-2536-31
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070581 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2536 N 0615-2536-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Oct 17, 1985TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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