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Generated: November 14, 2018

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Details for New Drug Application (NDA): 070184

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NDA 070184 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-four suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 070184
Tradename:METOCLOPRAMIDE HYDROCHLORIDE
Applicant:Teva
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070184
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 070184
Suppliers and Packaging for NDA: 070184
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070184 ANDA Teva Pharmaceuticals USA, Inc. 0093-2203 0093-2203-01 100 TABLET in 1 BOTTLE (0093-2203-01)
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070184 ANDA Teva Pharmaceuticals USA, Inc. 0093-2203 0093-2203-05 500 TABLET in 1 BOTTLE (0093-2203-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 29, 1985TE:ABRLD:No

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