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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021590

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NDA 021590 describes FAZACLO ODT, which is a drug marketed by Jazz Pharms Iii and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. 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 Pharms Iii
Ingredient:clozapine
Patents:2
Therapeutic Class:Antipsychotics
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 0093-3010 N 0093-3010-84
FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-3010 N 0093-3010-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:Feb 10, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength100MG
Approval Date:Feb 10, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021590

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz Pharms Iii FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-004 May 30, 2007 ➤ Sign Up ➤ Sign Up
Jazz Pharms Iii FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-004 May 30, 2007 ➤ Sign Up ➤ Sign Up
Jazz Pharms Iii FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-003 Jun 3, 2005 ➤ Sign Up ➤ Sign Up
Jazz Pharms Iii FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-003 Jun 3, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Citi
Covington
Cipla
Medtronic
Moodys
Dow
Express Scripts
Cantor Fitzgerald

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