FDA.reportPublic FDA data

Application 212888

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CABENUVACABOTEGRAVIR;RILPIVIRINETABLET, FILM COATED30MGNoNo
002CABENUVACABOTEGRAVIR;RILPIVIRINESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR600MG/3ML; 900MG/3MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-240Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-240Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-240Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-240Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-240Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-240Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-240Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-253Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-253Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-253Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-253Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-253Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-253Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent
49702-253Cabenuvacabotegravir and rilpivirineViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84337SUPPL 2025-11-28
84336SUPPL 2025-11-28
82009SUPPL 2025-04-25
81944SUPPL 2025-04-21
79750SUPPL 2024-09-26
79717SUPPL 2024-09-24
76831SUPPL 2023-12-14
76811SUPPL 2023-12-14
73625SUPPL 2023-02-28
73618SUPPL 2023-02-28
70661SUPPL2022-03-30
70660SUPPL2022-03-30
70653SUPPL2022-03-30
70652SUPPL2022-03-30
70598SUPPL2022-03-25
70595SUPPL2022-03-24
70143SUPPL2022-02-10
70135SUPPL2022-02-09
70060SUPPL2022-02-03
70044SUPPL2022-02-01
66474ORIG2021-03-03
65999ORIG2021-01-26
65964ORIG2021-01-22