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Generated: December 18, 2018

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Details for New Drug Application (NDA): 071402

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NDA 071402 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-three 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-four suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 071402
Tradename:METOCLOPRAMIDE HYDROCHLORIDE
Applicant:Ani Pharms
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071402
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 071402
Suppliers and Packaging for NDA: 071402
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride SOLUTION;ORAL 071402 ANDA ANI Pharmaceuticals, Inc. 62559-190 62559-190-16 473 mL in 1 BOTTLE, PLASTIC (62559-190-16)

Profile 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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