Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076809

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CLOZAPINE (CLOZAPINE)
50MG
Marketing Status: Prescription

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076809
Product Number: 003
Approval Date: Dec 16, 2005
Applicant Holder Full Name: IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

CLOZAPINE (CLOZAPINE)
100MG
Marketing Status: Prescription

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076809
Product Number: 002
Approval Date: Dec 16, 2005
Applicant Holder Full Name: IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

CLOZAPINE (CLOZAPINE)
200MG
Marketing Status: Prescription

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076809
Product Number: 001
Approval Date: Dec 16, 2005
Applicant Holder Full Name: IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information