BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cipla
Queensland Health
Mallinckrodt
Express Scripts
Baxter
Harvard Business School
UBS
Argus Health
QuintilesIMS
Cantor Fitzgerald

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077851

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NDA 077851 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lannett, Luitpold, Mylan Labs Ltd, Pliva Hrvatska Doo, Qilu Pharm Co Ltd, Sagent Pharms, Sandoz Inc, Sun Pharm Inds (in), Teva, West-ward Pharms Int, Wockhardt, Amneal Pharms, Apotex, Aurobindo Pharma, Silarx, Taro, Chartwell Molecules, Dr Reddys Labs Ltd, Glenmark Generics, Hikma Intl Pharms, Ipca Labs Ltd, Mylan, Natco Pharma Ltd, Sandoz, Emcure Pharms Ltd, Sun Pharm Inds Ltd, and Taro Pharms Ireland, and is included in sixty-eight NDAs. It is available from seventy-two 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-four suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 077851
Tradename:ONDANSETRON HYDROCHLORIDE
Applicant:Natco Pharma Ltd
Ingredient:ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077851
Suppliers and Packaging for NDA: 077851
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077851 ANDA KAISER FOUNDATION HOSPITALS 0179-0099 0179-0099-44 1440 TABLET in 1 BOTTLE (0179-0099-44)
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077851 ANDA KAISER FOUNDATION HOSPITALS 0179-0100 0179-0100-44 1440 TABLET in 1 BOTTLE (0179-0100-44)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jun 25, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Jun 25, 2007TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Cerilliant
Medtronic
US Army
Merck
Cantor Fitzgerald
Express Scripts
Baxter

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