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Details for New Drug Application (NDA): 020605

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NDA 020605 describes ZOFRAN, which is a drug marketed by Novartis Pharms Corp and Glaxosmithkline and is included in five NDAs. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZOFRAN profile page.

The generic ingredient in ZOFRAN is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-three suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ondansetron profile page.

Summary for NDA: 020605

Novartis Pharms Corp
ondansetron hydrochloride
Therapeutic Class:Antiemetics

Pharmacology for NDA: 020605

Suppliers and Packaging for NDA: 020605

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ondansetron hydrochloride
SOLUTION;ORAL 020605 NDA GlaxoSmithKline LLC 0173-0489 0173-0489-00 50 mL in 1 BOTTLE, GLASS (0173-0489-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 4MG BASE/5ML
Approval Date:Jan 24, 1997TE:AARLD:Yes
Patent:5,854,270*PEDPatent Expiration:May 20, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020605

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ondansetron hydrochloride
SOLUTION;ORAL020605-001Jan 24, 19974,695,578*PED<disabled>
Novartis Pharms Corp
ondansetron hydrochloride
SOLUTION;ORAL020605-001Jan 24, 19975,578,628*PED<disabled>
Novartis Pharms Corp
ondansetron hydrochloride
SOLUTION;ORAL020605-001Jan 24, 19975,854,270*PED<disabled>
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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.