Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208772

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ALUNBRIG (BRIGATINIB)
30MG
Marketing Status: Prescription

Active Ingredient: BRIGATINIB
Proprietary Name: ALUNBRIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208772
Product Number: 001
Approval Date: Apr 28, 2017
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ALUNBRIG (BRIGATINIB)
90MG
Marketing Status: Prescription

Active Ingredient: BRIGATINIB
Proprietary Name: ALUNBRIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208772
Product Number: 002
Approval Date: Apr 28, 2017
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ALUNBRIG (BRIGATINIB)
180MG
Marketing Status: Prescription

Active Ingredient: BRIGATINIB
Proprietary Name: ALUNBRIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208772
Product Number: 003
Approval Date: Oct 2, 2017
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information