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Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
AstraZeneca
Dow
Federal Trade Commission
Chinese Patent Office
Chubb
US Army
UBS
Queensland Health

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077557

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NDA 077557 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 077557

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

Pharmacology for NDA: 077557

Suppliers and Packaging for NDA: 077557

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 077557 ANDA Rebel Distributors Corp 42254-077 42254-077-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42254-077-30)
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 077557 ANDA Rebel Distributors Corp 42254-077 42254-077-10 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42254-077-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Aug 2, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength8MG
Approval Date:Aug 2, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Colorcon
Citi
Express Scripts
US Army
Fuji
Fish and Richardson
AstraZeneca
Medtronic
Cantor Fitzgerald
Covington

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