FDA.reportPublic FDA data

Application 210854

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XOFLUZABALOXAVIR MARBOXILTABLET;ORAL20MGYesNo
002XOFLUZABALOXAVIR MARBOXILTABLET;ORAL40MGYesYes
003XOFLUZABALOXAVIR MARBOXILTABLET;ORAL80MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4102XofluzaBALOXAVIR MARBOXILA-S Medication SolutionsNDACurrent
50090-4102XofluzaBALOXAVIR MARBOXILA-S Medication SolutionsNDACurrent
50090-4102XofluzaBALOXAVIR MARBOXILA-S Medication SolutionsNDACurrent
50090-4104XofluzaBALOXAVIR MARBOXILA-S Medication SolutionsNDACurrent
50090-4104XofluzaBALOXAVIR MARBOXILA-S Medication SolutionsNDACurrent
50090-4104XofluzaBALOXAVIR MARBOXILA-S Medication SolutionsNDACurrent
50242-583XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-583XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-583XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-583XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-583XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-583XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-583XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, IncNDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, IncNDACurrent
50242-828XofluzaBALOXAVIR MARBOXILGenentech, IncNDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, IncNDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, IncNDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-860XofluzaBALOXAVIR MARBOXILGenentech, IncNDACurrent
50242-877XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-877XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-877XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-877XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent
50242-877XofluzaBALOXAVIR MARBOXILGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82429SUPPL 2026-04-27
83422SUPPL 2025-09-23
82422SUPPL 2025-06-02
80682SUPPL 2024-12-23
80668SUPPL 2024-12-20
77706SUPPL 2024-03-04
77692SUPPL 2024-03-04
74532SUPPL 2023-06-16
74511SUPPL 2023-06-16
71801SUPPL2022-08-15
71800SUPPL2022-08-15
71792SUPPL2022-08-12
71791SUPPL2022-08-12
66083SUPPL2021-02-03
66082SUPPL2021-02-03
65348SUPPL2020-11-25
65347SUPPL2020-11-25
65325SUPPL2020-11-25
65324SUPPL2020-11-25
61082SUPPL2019-11-27
60576SUPPL2019-10-17
60578SUPPL2019-10-16
56648ORIG2018-12-07
56095ORIG2018-10-25
56094ORIG2018-10-25