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FDA NDA · NDA211994

DOVATO

dolutegravir sodium and lamivudine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA211994
TYPE
NDA
ORIGINAL APPROVAL
2019-04-08
LATEST ACTION
2025-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DOVATO · ReferencePrescription
DOLUTEGRAVIR SODIUM EQ 50MG BASE, LAMIVUDINE 300MG · TABLET · ORAL

Approval history

2025-10-28Labeling · Supplement 23 · standard — Label ↗AP
2024-04-18Labeling · Supplement 21 · standard — Label ↗AP
2024-04-05Efficacy · Supplement 18 · standard — Letter ↗AP
2024-04-05Efficacy · Supplement 19 · standard — Letter ↗AP
2023-11-03Manufacturing (CMC) · Supplement 20 — Letter ↗AP
2023-01-25Efficacy · Supplement 14 · standard — Letter ↗AP
2022-10-07Labeling · Supplement 15 · standard — Letter ↗AP
2022-01-20Efficacy · Supplement 13 · standard — Label ↗AP
2022-01-20Efficacy · Supplement 12 · standard — Label ↗AP
2021-03-23Labeling · Supplement 11 · standard — Letter ↗AP
2021-03-01Efficacy · Supplement 10 · standard — Letter ↗AP
2020-08-06Efficacy · Supplement 7 · standard — Letter ↗AP
2020-08-06Efficacy · Supplement 6 · standard — Letter ↗AP
2020-03-24Labeling · Supplement 4 · standard — Letter ↗AP
2019-10-24Labeling · Supplement 5 · standard — Letter ↗AP
2019-04-08Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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