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Serving leading biopharmaceutical companies globally:

Fish and Richardson
UBS
Novartis
Citi
Argus Health
Dow
Queensland Health
Healthtrust
Covington
McKinsey

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090648

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NDA 090648 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 090648
Tradename:ONDANSETRON HYDROCHLORIDE
Applicant:Gland Pharma Ltd
Ingredient:ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 090648
Suppliers and Packaging for NDA: 090648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 090648 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 090648 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Jun 15, 2012TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
US Army
Baxter
Covington
Cerilliant
Mallinckrodt
Chinese Patent Office
Teva
Cipla

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