Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202103

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DASATINIB (DASATINIB)
20MG
Marketing Status: Prescription

Active Ingredient: DASATINIB
Proprietary Name: DASATINIB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202103
Product Number: 001
Approval Date: Jun 10, 2016
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DASATINIB (DASATINIB)
50MG
Marketing Status: Prescription

Active Ingredient: DASATINIB
Proprietary Name: DASATINIB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202103
Product Number: 002
Approval Date: Jun 10, 2016
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DASATINIB (DASATINIB)
70MG
Marketing Status: Prescription

Active Ingredient: DASATINIB
Proprietary Name: DASATINIB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 70MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202103
Product Number: 003
Approval Date: Jun 10, 2016
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DASATINIB (DASATINIB)
100MG
Marketing Status: Prescription

Active Ingredient: DASATINIB
Proprietary Name: DASATINIB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202103
Product Number: 004
Approval Date: Jun 10, 2016
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information