← FDA DRUG APPROVALS

FDA NDA · NDA213983

TIVICAY PD

dolutegravir sodium

Sponsor: VIIV HLTHCARE

APPLICATION
NDA213983
TYPE
NDA
ORIGINAL APPROVAL
2020-06-12
LATEST ACTION
2025-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

TIVICAY PD · ReferencePrescription
DOLUTEGRAVIR SODIUM EQ 5MG BASE · TABLET, FOR SUSPENSION · ORAL

Approval history

2025-10-28Labeling · Supplement 6 · standard — Letter ↗AP
2024-04-18Labeling · Supplement 4 · standard — Label ↗AP
2022-10-07Labeling · Supplement 3 · standard — Letter ↗AP
2021-07-09Efficacy · Supplement 2 · standard — Label ↗AP
2021-03-23Labeling · Supplement 1 · standard — Letter ↗AP
2020-06-12Type 3 - New Dosage Form · Original · priority — Label ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →