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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 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 twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the clozapine profile page.

Summary for NDA: 021590

Tradename:
FAZACLO ODT
Applicant:
Jazz Pharms Iii
Ingredient:
clozapine
Patents:3
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 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:No
Patent:6,024,981Patent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,106,861Patent Expiration:Dec 5, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:6,221,392Patent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021590

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-004May 30, 20075,178,878► subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 20045,178,878► subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 20055,178,878► subscribe
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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.

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