Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212725

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ROZLYTREK (ENTRECTINIB)
100MG
Marketing Status: Prescription

Active Ingredient: ENTRECTINIB
Proprietary Name: ROZLYTREK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212725
Product Number: 001
Approval Date: Aug 15, 2019
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ROZLYTREK (ENTRECTINIB)
200MG
Marketing Status: Prescription

Active Ingredient: ENTRECTINIB
Proprietary Name: ROZLYTREK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212725
Product Number: 002
Approval Date: Aug 15, 2019
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information