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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203180

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DASATINIB (DASATINIB)
80MG
Marketing Status: Prescription
Active Ingredient: DASATINIB
Proprietary Name: DASATINIB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203180
Product Number: 001
Approval Date: Nov 23, 2021
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DASATINIB (DASATINIB)
140MG
Marketing Status: Prescription
Active Ingredient: DASATINIB
Proprietary Name: DASATINIB
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 140MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203180
Product Number: 002
Approval Date: Nov 23, 2021
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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