Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213411

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TUKYSA (TUCATINIB)
50MG
Marketing Status: Prescription

Active Ingredient: TUCATINIB
Proprietary Name: TUKYSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213411
Product Number: 001
Approval Date: Apr 17, 2020
Applicant Holder Full Name: SEAGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TUKYSA (TUCATINIB)
150MG
Marketing Status: Prescription

Active Ingredient: TUCATINIB
Proprietary Name: TUKYSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213411
Product Number: 002
Approval Date: Apr 17, 2020
Applicant Holder Full Name: SEAGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information