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Generated: November 20, 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 three 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-six suppliers are listed for this compound. Additional details are available on the ondansetron profile page.

Summary for 020781

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

Pharmacology for NDA: 020781

Medical Subject Heading (MeSH) Categories for 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 Novartis Pharmaceuticals Corporation 0078-0679 0078-0679-19 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0679-19) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0078-0679-61)
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL 020781 NDA Novartis Pharmaceuticals Corporation 0078-0680 0078-0680-19 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0680-19) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0078-0680-61)

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, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
AstraZeneca
Daiichi Sankyo
Chinese Patent Office
McKinsey
Harvard Business School
Julphar
Cantor Fitzgerald
Federal Trade Commission

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