Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214410

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XOFLUZA (BALOXAVIR MARBOXIL)
2MG/ML
Marketing Status: Prescription

Active Ingredient: BALOXAVIR MARBOXIL
Proprietary Name: XOFLUZA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 2MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214410
Product Number: 001
Approval Date: Nov 23, 2020
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XOFLUZA (BALOXAVIR MARBOXIL)
30MG/PACKET
Marketing Status: Prescription

Active Ingredient: BALOXAVIR MARBOXIL
Proprietary Name: XOFLUZA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 30MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214410
Product Number: 002
Approval Date: May 30, 2025
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XOFLUZA (BALOXAVIR MARBOXIL)
40MG/PACKET
Marketing Status: Prescription

Active Ingredient: BALOXAVIR MARBOXIL
Proprietary Name: XOFLUZA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 40MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214410
Product Number: 003
Approval Date: May 30, 2025
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information