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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079224

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NDA 079224 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 079224

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

Pharmacology for NDA: 079224

Suppliers and Packaging for NDA: 079224

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 079224 ANDA Pfizer Laboratories Div Pfizer Inc 0069-1441 0069-1441-40 1 VIAL, MULTI-DOSE in 1 CARTON (0069-1441-40) > 20 mL in 1 VIAL, MULTI-DOSE
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 079224 ANDA Pfizer Laboratories Div Pfizer Inc 0069-1441 0069-1441-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0069-1441-25) > 2 mL in 1 VIAL, SINGLE-DOSE (0069-1441-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Sep 25, 2009TE:APRLD:No


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