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Last Updated: December 22, 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. Twelve 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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 10, 2004TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 10, 2004TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 3, 2005TE:RLD:No

Expired US Patents for NDA 021590

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 ⤷  Subscribe ⤷  Subscribe
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-005 Jul 9, 2010 ⤷  Subscribe ⤷  Subscribe
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-006 Jul 9, 2010 ⤷  Subscribe ⤷  Subscribe
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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