← FDA DRUG APPROVALS

FDA NDA · NDA220092

PREZCOBIX

Sponsor: JANSSEN PRODS

APPLICATION
NDA220092
TYPE
NDA
ORIGINAL APPROVAL
2026-02-27
LATEST ACTION
2026-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

PREZCOBIXPrescription
DARUNAVIR AND COBICISTAT 675MG/150MG · TABLET, FOR SUSPENSION · ORAL
PREZCOBIXPrescription
DARUNAVIR AND COBICISTAT 600MG/90MG · TABLET, FOR SUSPENSION · ORAL
PREZCOBIX PED · ReferencePrescription
COBICISTAT 90MG, DARUNAVIR ETHANOLATE EQ 600MG BASE · TABLET, FOR SUSPENSION · ORAL

Approval history

2026-02-27Type 3 - New Dosage Form · Original · standard — 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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