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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021590

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FAZACLO ODT (CLOZAPINE)
12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: FAZACLO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021590
Product Number: 004
Approval Date: May 30, 2007
Applicant Holder Full Name: JAZZ PHARMACEUTICALS IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
FAZACLO ODT (CLOZAPINE)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: FAZACLO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021590
Product Number: 001
Approval Date: Feb 10, 2004
Applicant Holder Full Name: JAZZ PHARMACEUTICALS IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
FAZACLO ODT (CLOZAPINE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: FAZACLO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021590
Product Number: 003
Approval Date: Jun 3, 2005
Applicant Holder Full Name: JAZZ PHARMACEUTICALS IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
FAZACLO ODT (CLOZAPINE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: FAZACLO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021590
Product Number: 002
Approval Date: Feb 10, 2004
Applicant Holder Full Name: JAZZ PHARMACEUTICALS IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
FAZACLO ODT (CLOZAPINE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: FAZACLO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021590
Product Number: 005
Approval Date: Jul 9, 2010
Applicant Holder Full Name: JAZZ PHARMACEUTICALS IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
FAZACLO ODT (CLOZAPINE)
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: FAZACLO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021590
Product Number: 006
Approval Date: Jul 9, 2010
Applicant Holder Full Name: JAZZ PHARMACEUTICALS IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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