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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Daiichi Sankyo
AstraZeneca
Merck
Citi
Cipla
Novartis
Chinese Patent Office
US Department of Justice

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078807

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NDA 078807 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 078807
Tradename:METOCLOPRAMIDE HYDROCHLORIDE
Applicant:Ipca Labs Ltd
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078807
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 078807
Suppliers and Packaging for NDA: 078807
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 078807 ANDA Physicians Total Care, Inc. 54868-0034 54868-0034-4 30 TABLET in 1 BOTTLE, PLASTIC (54868-0034-4)
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 078807 ANDA Physicians Total Care, Inc. 54868-0034 54868-0034-5 50 TABLET in 1 BOTTLE, PLASTIC (54868-0034-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jun 12, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jun 12, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Novartis
Accenture
AstraZeneca
UBS
Argus Health
Colorcon
Express Scripts
Moodys

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