FDA.reportPublic FDA data

Application 211994

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOVATODOLUTEGRAVIR SODIUM; LAMIVUDINETABLET;ORALEQ 50MG BASE;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent
49702-246Dovatodolutegravir sodium and lamivudineViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83987SUPPL 2025-10-29
83974SUPPL 2025-10-29
78179SUPPL 2024-04-19
78094SUPPL 2024-04-09
78090SUPPL 2024-04-08
78084SUPPL 2024-04-08
78083SUPPL 2024-04-08
76555SUPPL 2023-11-13
76551SUPPL 2023-11-13
73325SUPPL2023-01-30
73294SUPPL2023-01-26
72305SUPPL2022-10-11
72290SUPPL2022-10-11
69949SUPPL2022-01-21
69948SUPPL2022-01-21
69945SUPPL2022-01-21
69944SUPPL2022-01-21
66876SUPPL2021-03-25
66860SUPPL2021-03-24
66453SUPPL2021-03-02
66447SUPPL2021-03-02
64240SUPPL2020-08-07
64239SUPPL2020-08-07
64231SUPPL2020-08-07
64230SUPPL2020-08-07
62314SUPPL2020-03-25
62312SUPPL2020-03-25
60681SUPPL2019-10-25
60671SUPPL2019-10-25
59165ORIG2019-06-24
58279ORIG2019-04-10
58267ORIG2019-04-10