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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Cantor Fitzgerald
Chinese Patent Office
Merck
Queensland Health
Fish and Richardson
Julphar
Deloitte
QuintilesIMS

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090424

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NDA 090424 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by 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), Teva, West-ward Pharms Int, Wockhardt, Amneal Pharms, Apotex, Aurobindo Pharma, Silarx, Taro, Chartwell Molecules, Dr Reddys Labs Ltd, Glenmark Generics, Hikma Intl Pharms, Ipca Labs Ltd, Mylan, Natco Pharma Ltd, Sandoz, Emcure Pharms Ltd, Sun Pharm Inds Ltd, and Taro Pharms Ireland, and is included in sixty-eight NDAs. It is available from seventy-two suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE 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 090424
Tradename:ONDANSETRON HYDROCHLORIDE
Applicant:Emcure Pharms
Ingredient:ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 090424
Suppliers and Packaging for NDA: 090424
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 090424 ANDA Heritage Pharmaceuticals Inc. 23155-168 23155-168-31 1 VIAL in 1 PACKAGE (23155-168-31) > 20 mL in 1 VIAL
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 090424 ANDA Heritage Pharmaceuticals Inc. 23155-377 23155-377-31 1 VIAL in 1 PACKAGE (23155-377-31) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Apr 16, 2010TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim
Dow
Deloitte
Colorcon
Fuji
Baxter
Federal Trade Commission
Covington

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