Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Healthtrust
Deloitte
Chinese Patent Office
US Army
Covington
Argus Health
McKinsey
Federal Trade Commission

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021590

« Back to Dashboard

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 three 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. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 021590

Tradename:1
Applicant:1
Ingredient:1
Patents:3
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 0093-3010-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-3010-01)
FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-3010 0093-3010-84 48 BLISTER PACK in 1 CARTON (0093-3010-84) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-3010-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:Feb 10, 2004TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Dec 5, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021590

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-005Jul 9, 2010► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-004May 30, 2007► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-006Jul 9, 2010► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 2004► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 2005► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 2005► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 2004► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 2004► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 2004► Subscribe► Subscribe
Jazz Pharms IiiFAZACLO ODTclozapineTABLET, ORALLY DISINTEGRATING;ORAL021590-004May 30, 2007► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Medtronic
UBS
Dow
QuintilesIMS
Chinese Patent Office
Accenture
Chubb
Fish and Richardson
Merck
Cerilliant

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot