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Serving 500+ biopharmaceutical companies globally:

Argus Health
Farmers Insurance
US Army
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Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071250

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NDA 071250 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-seven 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-eight suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 071250

Formulation / Manufacturing:see details

Pharmacology for NDA: 071250

Mechanism of ActionDopamine D2 Antagonists

Suppliers and Packaging for NDA: 071250

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metoclopramide hydrochloride
TABLET;ORAL 071250 ANDA Impax Generics 0115-1651 0115-1651-01 100 TABLET in 1 BOTTLE, PLASTIC (0115-1651-01)
metoclopramide hydrochloride
TABLET;ORAL 071250 ANDA Impax Generics 0115-1651 0115-1651-02 500 TABLET in 1 BOTTLE, PLASTIC (0115-1651-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 3, 1988TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Dec 28, 1995TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Express Scripts
US Department of Justice
Cantor Fitzgerald
Daiichi Sankyo

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