U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 218160

Expand all

RETEVMO (SELPERCATINIB)
40MG
Marketing Status: Prescription
Active Ingredient: SELPERCATINIB
Proprietary Name: RETEVMO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218160
Product Number: 001
Approval Date: Apr 10, 2024
Applicant Holder Full Name: LOXO ONCOLOGY A WHOLLY OWNED SUB OF ELI LILLY AND COMPANY
Marketing Status:  Prescription
Patent and Exclusivity Information
RETEVMO (SELPERCATINIB)
80MG
Marketing Status: Prescription
Active Ingredient: SELPERCATINIB
Proprietary Name: RETEVMO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218160
Product Number: 002
Approval Date: Apr 10, 2024
Applicant Holder Full Name: LOXO ONCOLOGY A WHOLLY OWNED SUB OF ELI LILLY AND COMPANY
Marketing Status:  Prescription
Patent and Exclusivity Information
RETEVMO (SELPERCATINIB)
120MG
Marketing Status: Prescription
Active Ingredient: SELPERCATINIB
Proprietary Name: RETEVMO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218160
Product Number: 003
Approval Date: Apr 10, 2024
Applicant Holder Full Name: LOXO ONCOLOGY A WHOLLY OWNED SUB OF ELI LILLY AND COMPANY
Marketing Status:  Prescription
Patent and Exclusivity Information
RETEVMO (SELPERCATINIB)
160MG
Marketing Status: Prescription
Active Ingredient: SELPERCATINIB
Proprietary Name: RETEVMO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 160MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218160
Product Number: 004
Approval Date: Apr 10, 2024
Applicant Holder Full Name: LOXO ONCOLOGY A WHOLLY OWNED SUB OF ELI LILLY AND COMPANY
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top