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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210496

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BRAFTOVI (ENCORAFENIB)
75MG
Marketing Status: Prescription
Active Ingredient: ENCORAFENIB
Proprietary Name: BRAFTOVI
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210496
Product Number: 002
Approval Date: Jun 27, 2018
Applicant Holder Full Name: ARRAY BIOPHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRAFTOVI (ENCORAFENIB)
50MG
Marketing Status: Discontinued
Active Ingredient: ENCORAFENIB
Proprietary Name: BRAFTOVI
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210496
Product Number: 001
Approval Date: Jun 27, 2018
Applicant Holder Full Name: ARRAY BIOPHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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