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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Cerilliant
Teva
Moodys
Dow
Novartis
US Army
Covington
Colorcon

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078152

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NDA 078152 describes ONDANSETRON, which is a drug marketed by Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Generics, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, 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), West-ward Pharms Int, Wockhardt, Amneal Pharms, Apotex, Silarx, Taro, Dr Reddys Labs Ltd, Hikma Intl Pharms, Ipca Labs Ltd, Natco Pharma Ltd, Emcure Pharms Ltd, and Taro Pharms Ireland, and is included in seventy-nine NDAs. It is available from thirty-three suppliers. Additional details are available on the ONDANSETRON profile page.

The generic ingredient in ONDANSETRON 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 078152

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

Pharmacology for NDA: 078152

Suppliers and Packaging for NDA: 078152

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078152 ANDA Stat Rx USA 16590-545 16590-545-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (16590-545-30)
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078152 ANDA Aidarex Pharmaceuticals LLC 33261-747 33261-747-01 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (33261-747-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Jun 27, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength8MG
Approval Date:Jun 27, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
McKinsey
Fish and Richardson
Medtronic
Express Scripts
Argus Health
Chubb
Cerilliant
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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