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Generated: November 15, 2018

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Details for New Drug Application (NDA): 078287

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NDA 078287 describes ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Mylan Labs Ltd, Sandoz Inc, Sun Pharm Inds Ltd, Taro Pharms Ireland, Teva, West-ward Pharms Int, and Wockhardt, and is included in twenty NDAs. It is available from fourteen suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 078287
Tradename:ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Baxter Hlthcare Corp
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078287
Suppliers and Packaging for NDA: 078287
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 078287 ANDA Baxter Healthcare Corporation 36000-012 36000-012-25 25 VIAL in 1 CARTON (36000-012-25) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Feb 22, 2013TE:APRLD:No

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