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Serving 500+ biopharmaceutical companies globally:

Citi
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Dow
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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077840

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NDA 077840 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 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 NDA: 077840

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

Pharmacology for NDA: 077840

Suppliers and Packaging for NDA: 077840

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION 077840 ANDA Hospira, Inc. 0409-1120 0409-1120-12 10 SYRINGE in 1 CARTON (0409-1120-12) > 2 mL in 1 SYRINGE (0409-1120-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Jan 19, 2007TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Julphar
Merck
Chinese Patent Office
Johnson and Johnson
Mallinckrodt
Cantor Fitzgerald
Cerilliant
Covington
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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