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Details for New Drug Application (NDA): 073118

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NDA 073118 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: 073118

Formulation / Manufacturing:see details

Pharmacology for NDA: 073118

Mechanism of ActionDopamine D2 Antagonists

Suppliers and Packaging for NDA: 073118

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metoclopramide hydrochloride
INJECTABLE;INJECTION 073118 ANDA Hospira, Inc. 0409-3414 0409-3414-01 25 VIAL, SINGLE-USE in 1 TRAY (0409-3414-01) > 2 mL in 1 VIAL, SINGLE-USE (0409-3414-18)
metoclopramide hydrochloride
INJECTABLE;INJECTION 073118 NDA General Injectables & Vaccines, Inc. 52584-414 52584-414-01 1 VIAL, SINGLE-DOSE in 1 BAG (52584-414-01) > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jan 17, 1991TE:APRLD:No

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