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Argus Health
US Army
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Merck
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Baxter

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077545

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NDA 077545 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, Casi Pharms Inc, Chartwell Molecules, Dr Reddys Labs Ltd, Glenmark Generics, Hikma Intl Pharms, Ipca Labs Ltd, Mylan, Natco Pharma Ltd, 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 077545
Tradename:ONDANSETRON HYDROCHLORIDE
Applicant:Hikma Intl Pharms
Ingredient:ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077545
Suppliers and Packaging for NDA: 077545
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077545 ANDA West-ward Pharmaceutical Corp 0143-2422 N 0143-2422-01
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077545 ANDA West-ward Pharmaceutical Corp 0143-2422 N 0143-2422-25

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Sep 6, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Sep 6, 2007TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 24MG BASE
Approval Date:Sep 6, 2007TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Cipla
Dow
McKesson
Harvard Business School
Argus Health
Johnson and Johnson
AstraZeneca
Healthtrust

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