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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Express Scripts
Cantor Fitzgerald
US Army
UBS
Argus Health
Moodys
Medtronic
QuintilesIMS

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206846

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NDA 206846 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: 206846

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

Pharmacology for NDA: 206846

Suppliers and Packaging for NDA: 206846

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION 206846 ANDA Accord Healthcare, Inc. 16729-298 16729-298-05 20 mL in 1 VIAL (16729-298-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Jul 13, 2015TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

UBS
Cerilliant
Daiichi Sankyo
Mallinckrodt
Colorcon
Medtronic
Deloitte
AstraZeneca
McKinsey
Cipla

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