← FDA DRUG APPROVALS

FDA NDA · NDA205551

TRIUMEQ

abacavir sulfate, dolutegravir sodium, lamivudine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA205551
TYPE
NDA
ORIGINAL APPROVAL
2014-08-22
LATEST ACTION
2025-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRIUMEQ · ReferencePrescription
ABACAVIR SULFATE EQ 600MG BASE, DOLUTEGRAVIR SODIUM EQ 50MG BASE, LAMIVUDINE 300MG · TABLET · ORAL

Approval history

2025-10-28Labeling · Supplement 34 · standard — Label ↗AP
2024-04-18Labeling · Supplement 32 · standard — Label ↗AP
2023-06-15Efficacy · Supplement 31 · priority — Label ↗AP
2022-10-07Labeling · Supplement 29 · standard — Label ↗AP
2022-03-30Efficacy · Supplement 28 · priority — Letter ↗AP
2021-03-23Labeling · Supplement 26 · standard — Letter ↗AP
2021-03-01Efficacy · Supplement 25 · standard — Letter ↗AP
2020-03-24Labeling · Supplement 21 · standard — Letter ↗AP
2019-10-24Labeling · Supplement 22 · standard — Letter ↗AP
2019-05-03Labeling · Supplement 16 · standard — Label ↗AP
2018-09-06Labeling · Supplement 15 · standard — Label ↗AP
2018-09-06Labeling · Supplement 14 · standard — Label ↗AP
2018-05-11Labeling · Supplement 13 · standard — Label ↗AP
2017-11-21Efficacy · Supplement 11 · priority — Label ↗AP
2017-03-27Labeling · Supplement 10 · standard — Label ↗AP
2016-04-21Efficacy · Supplement 5 · standard — Label ↗AP
2016-04-01Manufacturing (CMC) · Supplement 6 · standardAP
2015-09-28Labeling · Supplement 4 · standard — Label ↗AP
2015-08-05Labeling · Supplement 2 · standard — Letter ↗AP
2015-06-15Manufacturing (CMC) · Supplement 1 · standardAP
2014-08-22Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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