Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215039

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VIJOICE (ALPELISIB)
50MG
Marketing Status: Prescription

Active Ingredient: ALPELISIB
Proprietary Name: VIJOICE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215039
Product Number: 001
Approval Date: Apr 5, 2022
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

VIJOICE (ALPELISIB)
125MG
Marketing Status: Prescription

Active Ingredient: ALPELISIB
Proprietary Name: VIJOICE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215039
Product Number: 002
Approval Date: Apr 5, 2022
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

VIJOICE (ALPELISIB)
200MG
Marketing Status: Prescription

Active Ingredient: ALPELISIB
Proprietary Name: VIJOICE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215039
Product Number: 003
Approval Date: Apr 5, 2022
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information