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Fuji
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Federal Trade Commission
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Generated: April 25, 2018

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, Casi Pharms Inc, 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-eight NDAs. It is available from thirty-four 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-four suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 077557
Tradename:ONDANSETRON
Applicant:Sun Pharm Inds
Ingredient:ondansetron
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077557
Medical Subject Heading (MeSH) Categories for 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 E 42254-077-10
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 077557 ANDA Rebel Distributors Corp 42254-077 E 42254-077-30

Profile for product number 001

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

Profile 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 hundreds of leading biopharmaceutical companies globally:

Medtronic
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Cantor Fitzgerald
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