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Generated: September 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078139

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NDA 078139 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 Co Inc, 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, 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-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-five suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 078139
Tradename:ONDANSETRON
Applicant:Mylan
Ingredient:ondansetron
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078139
Medical Subject Heading (MeSH) Categories for 078139
Suppliers and Packaging for NDA: 078139
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078139 ANDA Mylan Pharmaceuticals Inc. 0378-7732 0378-7732-93 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-7732-93)
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078139 ANDA Mylan Pharmaceuticals Inc. 0378-7734 0378-7734-93 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-7734-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Jun 25, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength8MG
Approval Date:Jun 25, 2007TE:ABRLD:No

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