Drug application
PREZCOBIX PED (COBICISTAT, DARUNAVIR ETHANOLATE)
Drugs@FDA NDA 220092 · JANSSEN PRODS
Key facts
| Drug name | PREZCOBIX PED |
|---|---|
| Active ingredients | COBICISTAT, DARUNAVIR ETHANOLATE |
| Application type | NDA |
| Application number | 220092 |
| Company | JANSSEN PRODS |
| Dosage forms | TABLET, FOR SUSPENSION, ORAL |
| Strength | 90MG;EQ 600MG BASE |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Feb 27, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: