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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202806

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TAFINLAR (DABRAFENIB MESYLATE)
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: DABRAFENIB MESYLATE
Proprietary Name: TAFINLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202806
Product Number: 001
Approval Date: May 29, 2013
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
TAFINLAR (DABRAFENIB MESYLATE)
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: DABRAFENIB MESYLATE
Proprietary Name: TAFINLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202806
Product Number: 002
Approval Date: May 29, 2013
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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