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Ondansetron hydrochloride - Generic Drug Details

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Ondansetron hydrochloride is the generic ingredient in six branded drugs marketed by Aurobindo Pharma Ltd, Glaxosmithkline, Par Pharm, Novartis Pharms Corp, Apotex, Taro, Qilu Pharm Co Ltd, Eurohlth Intl Sarl, Pliva Hrvatska Doo, Taro Pharms Ireland, Lannett, Wockhardt, Sandoz, Emcure Pharms, Gland Pharma Ltd, Mylan, Luitpold, Glenmark Generics, Aurobindo Pharma, Hospira, Silarx, Apotex Inc, Mylan Labs Ltd, Accord Hlthcare, Emcure Pharms Ltd, Hikma Intl Pharms, Sun Pharm Inds (in), Natco Pharma Ltd, Teva, Fresenius Kabi Usa, Roxane, Ipca Labs Ltd, Sun Pharm Inds Ltd, Sagent Pharms, Hikma Farmaceutica, Amneal Pharms, Dr Reddys Labs Ltd, and Claris, and is included in seventy-one NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for ondansetron hydrochloride. Sixty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ondansetron hydrochloride

Tradenames:6
Patents:1
Applicants:38
NDAs:71
Drug Master File Entries: see list28
Suppliers / Packaging: see list69
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ondansetron hydrochloride

Tentative approvals for ONDANSETRON HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORALEQ 16MG
<disabled><disabled>TABLET; ORAL16MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro Pharms Ireland
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ondansetron hydrochloride
INJECTABLE;INJECTION078014-001Mar 21, 2008DISCNNo► subscribe► subscribe
Hikma Farmaceutica
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION076781-001Dec 26, 2006RXNo► subscribe► subscribe
Mylan
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL076930-004Jun 25, 2007RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: ondansetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ZOFRAN
ondansetron hydrochloride
TABLET;ORAL020103-003Aug 27, 19994,695,578*PED► subscribe
Novartis Pharms Corp
ZOFRAN
ondansetron hydrochloride
SOLUTION;ORAL020605-001Jan 24, 19974,753,789*PED► subscribe
Novartis Pharms Corp
ZOFRAN
ondansetron hydrochloride
TABLET;ORAL020103-003Aug 27, 19994,753,789*PED► subscribe
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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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