FDA.reportPublic FDA data

Application 215110

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAVYRETGLECAPREVIR; PIBRENTASVIRTABLET; ORAL100MG;40MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-2600MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2600MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2600MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2600MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2600MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82545SUPPL 2025-06-12
82535SUPPL 2025-06-11
75974SUPPL 2023-10-27
75949SUPPL 2023-10-26
69283ORIG2021-11-09
68863SUPPL2021-10-01
68803SUPPL2021-09-29
67885ORIG2021-06-24
67779ORIG2021-06-14