FDA.reportPublic FDA data

Application 215499

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APRETUDECABOTEGRAVIRFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR600MG/3ML (200MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-264ApretudeCabotegravirViiV Healthcare CompanyNDACurrent
49702-264ApretudeCabotegravirViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82007SUPPL 2025-04-25
81945SUPPL 2025-04-21
79749SUPPL 2024-09-26
79721SUPPL 2024-09-24
77595SUPPL 2024-02-22
76815SUPPL 2023-12-14
73627SUPPL 2023-02-28
73616SUPPL 2023-02-28
72048ORIG2022-09-09
69737ORIG2021-12-22
69698ORIG2021-12-20