Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218213

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AUGTYRO (REPOTRECTINIB)
40MG
Marketing Status: Prescription

Active Ingredient: REPOTRECTINIB
Proprietary Name: AUGTYRO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218213
Product Number: 001
Approval Date: Nov 15, 2023
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

AUGTYRO (REPOTRECTINIB)
160MG
Marketing Status: Prescription

Active Ingredient: REPOTRECTINIB
Proprietary Name: AUGTYRO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218213
Product Number: 002
Approval Date: Jun 11, 2024
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information