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Generated: October 17, 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 Chartwell Molecules, Mylan Labs Ltd, Apotex, Taro, Qilu Pharm Co Ltd, Pliva Hrvatska Doo, Lannett, Sandoz, Emcure Pharms, Gland Pharma Ltd, Sandoz Inc, Mylan, Glenmark Generics, Luitpold, Aurobindo Pharma, Hospira, Silarx, Hikma Intl Pharms, Accord Hlthcare, Sun Pharm Inds (in), Natco Pharma Ltd, Teva, West-ward Pharms Int, Ipca Labs Ltd, Apotex Inc, Fresenius Kabi Usa, Wockhardt, Sagent Pharms, Hikma Farmaceutica, Amneal Pharms, Dr Reddys Labs Ltd, Baxter Hlthcare Corp, Aurobindo Pharma Ltd, Taro Pharms Ireland, Emcure Pharms Ltd, and Sun Pharm Inds Ltd, and is included in sixty-eight NDAs. It is available from seventy 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-one suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for NDA: 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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