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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
US Department of Justice
Chinese Patent Office

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078602

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NDA 078602 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-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-five suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 078602
Applicant:Sun Pharm Inds Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 078602
Medical Subject Heading (MeSH) Categories for 078602
Suppliers and Packaging for NDA: 078602
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078602 ANDA Rnabaxy Pharmaceuticals Inc. 63304-346 N 63304-346-30
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078602 ANDA Rnabaxy Pharmaceuticals Inc. 63304-346 N 63304-346-05

Profile for product number 001

Approval Date:Feb 24, 2011TE:ABRLD:No

Profile for product number 002

Approval Date:Feb 24, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Federal Trade Commission
Boehringer Ingelheim
Chinese Patent Office
Johnson and Johnson

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