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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213246

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RETEVMO (SELPERCATINIB)
40MG
Marketing Status: Prescription
Active Ingredient: SELPERCATINIB
Proprietary Name: RETEVMO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213246
Product Number: 001
Approval Date: May 8, 2020
Applicant Holder Full Name: LOXO ONCOLOGY INC A WHOLLY OWNED SUB OF ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information
RETEVMO (SELPERCATINIB)
80MG
Marketing Status: Prescription
Active Ingredient: SELPERCATINIB
Proprietary Name: RETEVMO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213246
Product Number: 002
Approval Date: May 8, 2020
Applicant Holder Full Name: LOXO ONCOLOGY INC A WHOLLY OWNED SUB OF ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information
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