Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211155

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COPIKTRA (DUVELISIB)
15MG
Marketing Status: Prescription

Active Ingredient: DUVELISIB
Proprietary Name: COPIKTRA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211155
Product Number: 001
Approval Date: Sep 24, 2018
Applicant Holder Full Name: SECURA BIO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

COPIKTRA (DUVELISIB)
25MG
Marketing Status: Prescription

Active Ingredient: DUVELISIB
Proprietary Name: COPIKTRA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211155
Product Number: 002
Approval Date: Sep 24, 2018
Applicant Holder Full Name: SECURA BIO INC
Marketing Status:  Prescription
Patent and Exclusivity Information