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Serving leading biopharmaceutical companies globally:

Harvard Business School
UBS
Medtronic
Deloitte
Teva
Colorcon
QuintilesIMS
US Department of Justice
Citi
Fuji

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079224

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NDA 079224 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Chartwell Molecules, Mylan Labs Ltd, Apotex, Taro, Qilu Pharm Co Ltd, Pliva Hrvatska Doo, Lannett, Sandoz, Emcure Pharms, Gland Pharma Ltd, Sandoz Inc, Mylan, Glenmark Generics, Luitpold, Aurobindo Pharma, Hospira, Silarx, Hikma Intl Pharms, Accord Hlthcare, Sun Pharm Inds (in), Natco Pharma Ltd, Teva, West-ward Pharms Int, Ipca Labs Ltd, Apotex Inc, Fresenius Kabi Usa, Wockhardt, Sagent Pharms, Hikma Farmaceutica, Amneal Pharms, Dr Reddys Labs Ltd, Baxter Hlthcare Corp, Aurobindo Pharma Ltd, Taro Pharms Ireland, Emcure Pharms Ltd, and Sun Pharm Inds Ltd, and is included in sixty-eight NDAs. It is available from sixty-nine suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for NDA: 079224

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 079224

Suppliers and Packaging for NDA: 079224

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION 079224 ANDA Pfizer Laboratories Div Pfizer Inc 0069-1441 0069-1441-40 1 VIAL, MULTI-DOSE in 1 CARTON (0069-1441-40) > 20 mL in 1 VIAL, MULTI-DOSE
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION 079224 ANDA Pfizer Laboratories Div Pfizer Inc 0069-1441 0069-1441-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0069-1441-25) > 2 mL in 1 VIAL, SINGLE-DOSE (0069-1441-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Sep 25, 2009TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Citi
Fish and Richardson
Chubb
Accenture
Farmers Insurance
McKinsey
Argus Health
McKesson
Harvard Business School
Novartis

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