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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211710

VITRAKVI (LAROTRECTINIB SULFATE)
EQ 20MG BASE/ML
Marketing Status: Prescription
Active Ingredient: LAROTRECTINIB SULFATE
Proprietary Name: VITRAKVI
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 20MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211710
Product Number: 001
Approval Date: Nov 26, 2018
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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