Application 214787

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VEKLURYREMDESIVIRINJECTABLE;INJECTION5MG/MLYesNo
002VEKLURYREMDESIVIRINJECTABLE;INJECTION100MG/VIALYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2901VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2902VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2902VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2902VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2902VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2902VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2902VekluryremdesivirGilead Sciences, Inc.NDACurrent
61958-2902VekluryremdesivirGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83718SUPPL 2025-10-10
83690SUPPL 2025-10-08
83199SUPPL 2025-08-26
83182SUPPL 2025-08-25
80842SUPPL 2025-01-13
80840SUPPL 2025-01-13
80684SUPPL 2024-12-23
80662SUPPL 2024-12-20
78931SUPPL 2024-06-28
78926SUPPL 2024-06-28
77682SUPPL 2024-03-01
77658SUPPL 2024-02-29
77648SUPPL 2024-02-28
75274SUPPL 2023-08-24
75266SUPPL 2023-08-23
75123SUPPL 2023-08-18
75116SUPPL 2023-08-18
74758SUPPL 2023-07-14
74756SUPPL 2023-07-13
74488SUPPL 2023-06-13
74483SUPPL 2023-06-13
74469SUPPL 2023-06-09
74463SUPPL 2023-06-08
74142SUPPL 2023-05-02
74122SUPPL 2023-05-01
73908SUPPL 2023-03-30
73905SUPPL 2023-03-30
72908SUPPL2022-12-15
72895SUPPL2022-12-15
72482SUPPL2022-10-27
72463SUPPL2022-10-25
72216SUPPL2022-10-03
72189SUPPL2022-09-30
71451SUPPL2022-06-27
71449SUPPL2022-06-24
71444SUPPL2022-06-24
70870SUPPL2022-05-02
70818SUPPL2022-04-27
70813SUPPL2022-04-26
70606SUPPL2022-03-25
70604SUPPL2022-03-25
70346SUPPL2022-03-02
69975SUPPL2022-01-26
69953SUPPL2022-01-24
69951SUPPL2022-01-21
69935SUPPL2022-01-20
69929SUPPL2022-01-20
66353SUPPL2021-02-24
66340SUPPL2021-02-23
65346ORIG2020-11-25
64980ORIG2020-10-22
64979ORIG2020-10-22
64978ORIG2020-10-22