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Last Updated: March 19, 2026

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. Thirteen 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

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TABLET, ORALLY DISINTEGRATING;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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TABLET, ORALLY DISINTEGRATING;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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TABLET, ORALLY DISINTEGRATING;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	Yes

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	021590-001	Feb 10, 2004	6,221,392	⤷ Get Started Free
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-004	May 30, 2007	5,178,878	⤷ Get Started Free
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-006	Jul 9, 2010	6,024,981	⤷ Get Started Free
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-005	Jul 9, 2010	6,221,392	⤷ Get Started Free
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-002	Feb 10, 2004	6,221,392	⤷ Get Started Free
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-001	Feb 10, 2004	5,178,878	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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