FDA.reportPublic FDA data

Application 210192

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JULUCADOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDETABLET;ORALEQ 50MG BASE;EQ 25MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-242Julucadolutegravir sodium and rilpivirine hydrochlorideViiV Healthcare CompanyNDACurrent
49702-242Julucadolutegravir sodium and rilpivirine hydrochlorideViiV Healthcare CompanyNDACurrent
49702-242Julucadolutegravir sodium and rilpivirine hydrochlorideViiV Healthcare CompanyNDACurrent
49702-242Julucadolutegravir sodium and rilpivirine hydrochlorideViiV Healthcare CompanyNDACurrent
49702-242Julucadolutegravir sodium and rilpivirine hydrochlorideViiV Healthcare CompanyNDACurrent
49702-242Julucadolutegravir sodium and rilpivirine hydrochlorideViiV Healthcare CompanyNDACurrent
49702-242Julucadolutegravir sodium and rilpivirine hydrochlorideViiV Healthcare CompanyNDACurrent
49702-242Julucadolutegravir sodium and rilpivirine hydrochlorideViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83986SUPPL 2025-10-29
83972SUPPL 2025-10-28
78178SUPPL 2024-04-19
78167SUPPL 2024-04-19
72304SUPPL2022-10-11
72289SUPPL2022-10-11
68058SUPPL2021-07-13
68052SUPPL2021-07-12
66875SUPPL2021-03-25
66858SUPPL2021-03-24
63962SUPPL2020-07-20
63928SUPPL2020-07-15
60680SUPPL2019-10-25
60670SUPPL2019-10-25
55449SUPPL2018-09-12
55448SUPPL2018-09-12
55430SUPPL2018-09-11
55429SUPPL2018-09-11
54738ORIG2018-07-02
51864SUPPL2018-01-26
51081SUPPL2018-01-18
50503ORIG2017-11-27
50479ORIG2017-11-24