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Generated: November 18, 2018

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Details for New Drug Application (NDA): 077716

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NDA 077716 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 077716
Tradename:ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Wockhardt
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077716
Suppliers and Packaging for NDA: 077716
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077716 ANDA WOCKHARDT LIMITED 55648-726 55648-726-01 5 VIAL, SINGLE-DOSE in 1 CARTON (55648-726-01) > 2 mL in 1 VIAL, SINGLE-DOSE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077716 ANDA Wockhardt USA LLC. 64679-726 64679-726-01 5 VIAL, SINGLE-DOSE in 1 CARTON (64679-726-01) > 2 mL in 1 VIAL, SINGLE-DOSE (64679-726-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Dec 26, 2006TE:APRLD:No

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