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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203711

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NDA 203711 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 sixty-nine 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 suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for 203711

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

Pharmacology for NDA: 203711

Suppliers and Packaging for NDA: 203711

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 203711 ANDA Apotex Corp. 60505-6130 60505-6130-5 25 VIAL, SINGLE-USE in 1 CARTON (60505-6130-5) > 2 mL in 1 VIAL, SINGLE-USE
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 203711 ANDA Qilu Pharmaceutical Co., Ltd. 67184-0507 67184-0507-5 5 VIAL, SINGLE-USE in 1 CARTON (67184-0507-5) > 2 mL in 1 VIAL, SINGLE-USE (67184-0507-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Sep 8, 2014TE:APRLD:No


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Dow

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