| PREZCOBIX |
205395 |
001 |
NDA |
COBICISTAT; DARUNAVIR ETHANOLATE |
TABLET;ORAL |
150MG;EQ 800MG BASE |
Yes
|
Yes
|
2015/01/29
|
2015/01/29
|
JANSSEN PRODS |
Prescription |
| PREZCOBIX |
205395 |
002 |
NDA |
COBICISTAT; DARUNAVIR ETHANOLATE |
TABLET;ORAL |
150MG;EQ 675MG BASE |
Yes
|
Yes
|
2015/01/29
|
2025/03/21
|
JANSSEN PRODS |
Prescription |
| PREZCOBIX PED |
220092 |
001 |
NDA |
COBICISTAT; DARUNAVIR ETHANOLATE |
TABLET, FOR SUSPENSION;ORAL |
90MG;EQ 600MG BASE |
Yes
|
Yes
|
2026/02/27
|
2026/02/27
|
JANSSEN PRODS |
Prescription |
| PREZCOBIX |
220092 |
002 |
NDA |
DARUNAVIR AND COBICISTAT |
TABLET, FOR SUSPENSION;ORAL |
675MG/150MG |
No
|
No
|
2026/02/27
|
--
|
JANSSEN PRODS |
Prescription |
| PREZCOBIX |
220092 |
003 |
NDA |
DARUNAVIR AND COBICISTAT |
TABLET, FOR SUSPENSION;ORAL |
600MG/90MG |
No
|
No
|
2026/02/27
|
--
|
JANSSEN PRODS |
Prescription |