Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019758

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CLOZARIL (CLOZAPINE)
25MG
Marketing Status: Prescription

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZARIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019758
Product Number: 001
Approval Date: Sep 26, 1989
Applicant Holder Full Name: HERITAGE LIFE SCIENCES BARBADOS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CLOZARIL (CLOZAPINE)
100MG
Marketing Status: Prescription

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZARIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019758
Product Number: 002
Approval Date: Sep 26, 1989
Applicant Holder Full Name: HERITAGE LIFE SCIENCES BARBADOS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CLOZARIL (CLOZAPINE)
50MG
Marketing Status: Discontinued

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZARIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019758
Product Number: 003
Approval Date: May 20, 2019
Applicant Holder Full Name: HERITAGE LIFE SCIENCES BARBADOS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

CLOZARIL (CLOZAPINE)
200MG
Marketing Status: Discontinued

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZARIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019758
Product Number: 004
Approval Date: May 20, 2019
Applicant Holder Full Name: HERITAGE LIFE SCIENCES BARBADOS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information