FDA.reportPublic FDA data

Application 205551

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIUMEQABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINETABLET;ORALEQ 600MG BASE;EQ 50MG BASE;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
49702-231Triumeqabacavir sulfate, dolutegravir sodium, lamivudineViiV Healthcare CompanyNDACurrent
50090-1606Triumeqabacavir sulfate, dolutegravir sodium, lamivudineA-S Medication SolutionsNDACurrent
50090-1606Triumeqabacavir sulfate, dolutegravir sodium, lamivudineA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83984SUPPL 2025-10-29
83971SUPPL 2025-10-29
83970SUPPL 2025-10-29
78172SUPPL 2024-04-19
78163SUPPL 2024-04-19
74522SUPPL 2023-06-16
74507SUPPL 2023-06-16
72314SUPPL2022-10-11
72301SUPPL2022-10-11
72300SUPPL2022-10-11
70672SUPPL2022-03-31
70671SUPPL2022-03-31
70666SUPPL2022-03-31
66866SUPPL2021-03-25
66865SUPPL2021-03-25
66857SUPPL2021-03-24
66452SUPPL2021-03-02
66451SUPPL2021-03-02
66445SUPPL2021-03-02
62315SUPPL2020-03-25
62310SUPPL2020-03-25
60690SUPPL2019-10-28
60689SUPPL2019-10-28
60669SUPPL2019-10-25
58610SUPPL2019-05-08
58598SUPPL2019-05-07
55451SUPPL2018-09-12
55450SUPPL2018-09-12
55422SUPPL2018-09-10
55421SUPPL2018-09-10
54200SUPPL2018-05-16
54178SUPPL2018-05-14
50500SUPPL2017-11-27
50483SUPPL2017-11-24
47761SUPPL2017-03-29
47733SUPPL2017-03-28
40474SUPPL2016-04-27
10461SUPPL2016-04-22
40473SUPPL2015-10-07
10460SUPPL2015-09-30
43490ORIG2015-08-11
10459SUPPL2015-08-10
19656SUPPL2015-08-07
32684ORIG2014-08-27
19655ORIG2014-08-26
51222SUPPL1900-01-01
51221SUPPL1900-01-01