← FDA DRUG APPROVALS

FDA NDA · NDA215413

TRIUMEQ PD

abacavir sulfate, dolutegravir sodium, lamivudine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA215413
TYPE
NDA
ORIGINAL APPROVAL
2022-03-30
LATEST ACTION
2025-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

TRIUMEQ PD · ReferencePrescription
ABACAVIR SULFATE EQ 60MG BASE, DOLUTEGRAVIR SODIUM EQ 5MG BASE, LAMIVUDINE 30MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2025-10-28Labeling · Supplement 5 · standard — Label ↗AP
2024-04-18Labeling · Supplement 3 · standard — Label ↗AP
2023-06-15Efficacy · Supplement 2 · priority — Label ↗AP
2022-10-07Labeling · Supplement 1 · standard — Letter ↗AP
2022-03-30Type 3 - New Dosage Form · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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