Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210854

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XOFLUZA (BALOXAVIR MARBOXIL)
40MG
Marketing Status: Prescription

Active Ingredient: BALOXAVIR MARBOXIL
Proprietary Name: XOFLUZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210854
Product Number: 002
Approval Date: Oct 24, 2018
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XOFLUZA (BALOXAVIR MARBOXIL)
80MG
Marketing Status: Prescription

Active Ingredient: BALOXAVIR MARBOXIL
Proprietary Name: XOFLUZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210854
Product Number: 003
Approval Date: Mar 18, 2021
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XOFLUZA (BALOXAVIR MARBOXIL)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: BALOXAVIR MARBOXIL
Proprietary Name: XOFLUZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210854
Product Number: 001
Approval Date: Oct 24, 2018
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information