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Details for New Drug Application (NDA): 020781

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NDA 020781 describes ZOFRAN ODT, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the ZOFRAN ODT profile page.

The generic ingredient in ZOFRAN ODT 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: 020781

Tradename:
ZOFRAN ODT
Applicant:
Novartis Pharms Corp
Ingredient:
ondansetron
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 020781

Suppliers and Packaging for NDA: 020781

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL 020781 NDA GlaxoSmithKline LLC 0173-0569 0173-0569-00 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (0173-0569-00)
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL 020781 NDA GlaxoSmithKline LLC 0173-0570 0173-0570-00 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (0173-0570-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Jan 27, 1999TE:ABRLD:No
Patent:5,955,488*PEDPatent Expiration:May 14, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,063,802*PEDPatent Expiration:May 14, 2016Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength8MG
Approval Date:Jan 27, 1999TE:ABRLD:Yes
Patent:5,955,488*PEDPatent Expiration:May 14, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020781

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 19994,695,578*PED► subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 19996,063,802*PED► subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 19994,695,578*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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