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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210259

Marketing Status: Prescription
Active Ingredient: ACALABRUTINIB
Proprietary Name: CALQUENCE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210259
Product Number: 001
Approval Date: Oct 31, 2017
Applicant Holder Full Name: ASTRAZENECA UK LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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