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Generated: January 22, 2019

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Details for New Drug Application (NDA): 204756

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NDA 204756 describes METOCLOPRAMIDE, which is a drug marketed by Emcure Pharms Ltd, 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-five NDAs. It is available from one supplier. Additional details are available on the METOCLOPRAMIDE profile page.

The generic ingredient in METOCLOPRAMIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 204756
Applicant:Emcure Pharms Ltd
Ingredient:metoclopramide hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 204756
Mechanism of ActionDopamine D2 Antagonists
Medical Subject Heading (MeSH) Categories for 204756
Suppliers and Packaging for NDA: 204756
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOCLOPRAMIDE metoclopramide hydrochloride INJECTABLE;INJECTION 204756 ANDA Heritage Pharmaceuticals Inc. 23155-240 23155-240-41 25 VIAL in 1 CARTON (23155-240-41) > 2 mL in 1 VIAL (23155-240-31)
METOCLOPRAMIDE metoclopramide hydrochloride INJECTABLE;INJECTION 204756 ANDA Heritage Pharmaceuticals Inc. 23155-240 23155-240-42 25 VIAL in 1 CARTON (23155-240-42) > 10 mL in 1 VIAL (23155-240-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength EQ 5MG BASE/ML
Approval Date:Dec 20, 2013TE:APRLD:No

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