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Last Updated: July 10, 2020

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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. It is available from two suppliers. 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
Pharmacology for NDA: 021590
Medical Subject Heading (MeSH) Categories for 021590
Suppliers and Packaging for NDA: 021590
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-3086 0093-3086-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-3086-01)
FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-3086 0093-3086-19 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-3086-19)
Paragraph IV (Patent) Challenges for 021590
Tradename Dosage Ingredient NDA Submissiondate
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2011-04-18
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2011-04-08
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2008-06-05
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2008-04-28

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:Feb 10, 2004TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength100MG
Approval Date:Feb 10, 2004TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength50MG
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 021590-006 Jul 9, 2010   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-005 Jul 9, 2010   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-001 Feb 10, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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