Details for New Drug Application (NDA): 020781

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NDA 020781 describes ZOFRAN ODT, which is a drug marketed by Sandoz and is included in one NDA. 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:	ZOFRAN ODT
Applicant:	Sandoz
Ingredient:	ondansetron
Patents:	0

Medical Subject Heading (MeSH) Categories for 020781

Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Serotonin Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 27, 1999	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 27, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020781

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	6,063,802*PED	⤷ Subscribe
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	6,063,802*PED	⤷ Subscribe
Sandoz	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	5,955,488*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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