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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 219249

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ITOVEBI (INAVOLISIB)
3MG
Marketing Status: Prescription
Active Ingredient: INAVOLISIB
Proprietary Name: ITOVEBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N219249
Product Number: 001
Approval Date: Oct 10, 2024
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ITOVEBI (INAVOLISIB)
9MG
Marketing Status: Prescription
Active Ingredient: INAVOLISIB
Proprietary Name: ITOVEBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N219249
Product Number: 002
Approval Date: Oct 10, 2024
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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