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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072801

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NDA 072801 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, 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, and Watson Labs, and is included in fifty-three NDAs. It is available from forty-five 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-six suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 072801
Tradename:METOCLOPRAMIDE HYDROCHLORIDE
Applicant:Teva
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 072801
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 072801
Suppliers and Packaging for NDA: 072801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 072801 ANDA Teva Pharmaceuticals USA, Inc. 0093-2204 0093-2204-01 100 TABLET in 1 BOTTLE (0093-2204-01)
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 072801 ANDA Teva Pharmaceuticals USA, Inc. 0093-2204 0093-2204-05 500 TABLET in 1 BOTTLE (0093-2204-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jun 15, 1993TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Accenture
Teva
QuintilesIMS
US Army
Johnson and Johnson
Farmers Insurance
Cipla
Express Scripts
Deloitte

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