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Generated: January 19, 2019

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Details for New Drug Application (NDA): 206845

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NDA 206845 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 fifteen 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-eight suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 206845
Tradename:ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Accord Hlthcare
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206845
Suppliers and Packaging for NDA: 206845
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 206845 ANDA Accord Healthcare, Inc. 16729-297 16729-297-83 5 VIAL in 1 CARTON (16729-297-83) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Mar 10, 2016TE:APRLD:No

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