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Generated: August 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071402

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NDA 071402 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-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 NDA: 071402

Formulation / Manufacturing:see details

Pharmacology for NDA: 071402

Mechanism of ActionDopamine D2 Antagonists

Suppliers and Packaging for NDA: 071402

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metoclopramide hydrochloride
SOLUTION;ORAL 071402 ANDA ANI Pharmaceuticals, Inc. 62559-190 62559-190-16 473 mL in 1 BOTTLE, PLASTIC (62559-190-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 5MG BASE/5ML
Approval Date:Jun 25, 1993TE:AARLD:No

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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Daiichi Sankyo
US Army

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