Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090308

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CLOZAPINE (CLOZAPINE)
12.5MG
Marketing Status: Prescription

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A090308
Product Number: 003
Approval Date: Apr 9, 2018
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CLOZAPINE (CLOZAPINE)
25MG
Marketing Status: Prescription

Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090308
Product Number: 001
Approval Date: Nov 25, 2015
Applicant Holder Full Name: BARR LABORATORIES INC
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, ORALLY DISINTEGRATING; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A090308
Product Number: 002
Approval Date: Nov 25, 2015
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information