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Generated: April 29, 2017

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Details for New Drug Application (NDA): 070363

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NDA 070363 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Teva, Ani Pharms, Wockhardt, Hospira, Halsey, Ipca Labs Ltd, Watson Labs, Interpharm, Sandoz, Smith And Nephew, Superpharm, Teva Pharms Usa, Sun Pharm Inds, Roxane, Clonmel, Usl Pharma, Actavis Mid Atlantic, Par Pharm, Bedford, Pharm Assoc, Morton Grove, Impax Labs Inc, Vistapharm, Mutual Pharm, Paco, Northstar Hlthcare, Vintage Pharms, Silarx, Par Pharm Inc, Novel Labs Inc, Fresenius Kabi Usa, Norbrook, Lyphomed, and Schering, and is included in fifty-three NDAs. It is available from forty-nine 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. Fifty-one suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 070363

Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 2, 1987TE:RLD:No

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