← FDA DRUG APPROVALS

FDA NDA · NDA210192

JULUCA

dolutegravir sodium and rilpivirine hydrochloride

Sponsor: VIIV HLTHCARE

APPLICATION
NDA210192
TYPE
NDA
ORIGINAL APPROVAL
2017-11-21
LATEST ACTION
2025-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JULUCA · ReferencePrescription
DOLUTEGRAVIR SODIUM EQ 50MG BASE, RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL

Approval history

2025-10-28Labeling · Supplement 17 · standard — Label ↗AP
2024-04-18Labeling · Supplement 14 · standard — Letter ↗AP
2022-10-07Labeling · Supplement 13 · standard — Letter ↗AP
2021-07-09Efficacy · Supplement 11 · standard — Label ↗AP
2021-03-23Labeling · Supplement 12 · standard — Letter ↗AP
2020-07-14Efficacy · Supplement 7 · standard — Label ↗AP
2019-10-24Labeling · Supplement 8 · standard — Letter ↗AP
2018-09-06Labeling · Supplement 4 · standard — Label ↗AP
2018-09-06Labeling · Supplement 2 · standard — Label ↗AP
2018-01-17Labeling · Supplement 1 · standard — Label ↗AP
2017-11-21Type 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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