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Generated: July 23, 2017

DrugPatentWatch Database Preview

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 two suppliers. 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-five suppliers are listed for this compound. Additional details are available on the ondansetron profile page.

Summary for NDA: 020781

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength8MG
Approval Date:Jan 27, 1999TE:ABRLD:Yes

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;ORAL020781-001Jan 27, 19996,063,802*PED► Subscribe
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;ORAL020781-001Jan 27, 19994,695,578*PED► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 19994,753,789*PED► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 19995,578,628*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Deloitte
US Army
Julphar
Farmers Insurance
Fish and Richardson
QuintilesIMS
Moodys
Accenture
Merck
Cantor Fitzgerald

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