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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 021590

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NDA 021590 describes FAZACLO ODT, which is a drug marketed by Jazz and is included in one NDA. Additional details are available on the FAZACLO ODT profile page.

The generic ingredient in FAZACLO ODT is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 021590

Tradename:	FAZACLO ODT
Applicant:	Jazz
Ingredient:	clozapine
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 021590

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 10, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 10, 2004	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 3, 2005	TE:		RLD:	No

Expired US Patents for NDA 021590

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-003	Jun 3, 2005	⤷ Try a Trial	⤷ Try a Trial
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-001	Feb 10, 2004	⤷ Try a Trial	⤷ Try a Trial
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-004	May 30, 2007	⤷ Try a Trial	⤷ Try a Trial
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-002	Feb 10, 2004	⤷ Try a Trial	⤷ Try a Trial
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-004	May 30, 2007	⤷ Try a Trial	⤷ Try a Trial
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-004	May 30, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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 verification 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.