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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206845

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NDA 206845 describes ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Aurobindo Pharma Ltd, West-ward Pharms Int, Taro Pharms Ireland, Wockhardt, Luitpold, Apotex Inc, Mylan Labs Ltd, Accord Hlthcare, Emcure Pharms Ltd, Hospira, Sandoz Inc, Fresenius Kabi Usa, Teva, Sun Pharm Inds Ltd, Hikma Farmaceutica, and Claris, and is included in twenty NDAs. It is available from fifteen suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for NDA: 206845

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

Pharmacology for NDA: 206845

Suppliers and Packaging for NDA: 206845

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ondansetron hydrochloride
INJECTABLE;INJECTION 206845 ANDA Accord Healthcare, Inc. 16729-297 16729-297-83 5 VIAL in 1 CARTON (16729-297-83) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Mar 10, 2016TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Johnson and Johnson
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Daiichi Sankyo
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Dow
Harvard Business School

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