← FDA DRUG APPROVALS

FDA NDA · NDA205395

PREZCOBIX

darunavir ethanolate and cobicistat

Sponsor: JANSSEN PRODS

APPLICATION
NDA205395
TYPE
NDA
ORIGINAL APPROVAL
2015-01-29
LATEST ACTION
2026-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PREZCOBIX · ReferencePrescription
COBICISTAT 150MG, DARUNAVIR ETHANOLATE EQ 675MG BASE · TABLET · ORAL
PREZCOBIX · ReferencePrescription
COBICISTAT 150MG, DARUNAVIR ETHANOLATE EQ 800MG BASE · TABLET · ORAL

Approval history

2026-02-27Efficacy · Supplement 29 · standard — Letter ↗AP
2025-03-21Efficacy · Supplement 28 · standard — Label ↗AP
2023-03-31Labeling · Supplement 25 · standard — Label ↗AP
2022-10-20Labeling · Supplement 24 · standard — Letter ↗AP
2022-04-14Labeling · Supplement 22 · standard — Letter ↗AP
2021-07-23Labeling · Supplement 20 · standard — Label ↗AP
2020-12-22Labeling · Supplement 18 · standard — Letter ↗AP
2020-07-31Efficacy · Supplement 16 · standard — Letter ↗AP
2019-05-29Labeling · Supplement 14 · standard — Label ↗AP
2019-01-28Labeling · Supplement 12 · standard — Label ↗AP
2018-09-07Labeling · Supplement 10 · standard — Label ↗AP
2018-06-04Efficacy · Supplement 9 · priority — Label ↗AP
2018-01-25Labeling · Supplement 6 · standard — Letter ↗AP
2018-01-25Labeling · Supplement 7 · standard — Letter ↗AP
2017-06-14Labeling · Supplement 4 · standard — Label ↗AP
2016-09-22Labeling · Supplement 2 · standard — Label ↗AP
2016-03-31Labeling · Supplement 1 · standard — Letter ↗AP
2015-01-29Type 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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