Product Details for ANDA 209480
CLOZAPINE (CLOZAPINE)
25MG
Marketing Status: Discontinued
50MG
Marketing Status: Discontinued
100MG
Marketing Status: Discontinued
200MG
Marketing Status: Discontinued
25MG
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A209480
Product Number: 001
Approval Date: Dec 6, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CLOZAPINE (CLOZAPINE)
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A209480
Product Number: 001
Approval Date: Dec 6, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A209480
Product Number: 002
Approval Date: Dec 6, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CLOZAPINE (CLOZAPINE)
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A209480
Product Number: 002
Approval Date: Dec 6, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
100MG
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A209480
Product Number: 003
Approval Date: Dec 6, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CLOZAPINE (CLOZAPINE)
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A209480
Product Number: 003
Approval Date: Dec 6, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG
Marketing Status: Discontinued
Active Ingredient: CLOZAPINE
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A209480
Product Number: 004
Approval Date: Dec 6, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CLOZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A209480
Product Number: 004
Approval Date: Dec 6, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information