Application 220092
- Type
- NDA
- Sponsor
- JANSSEN PRODS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREZCOBIX PED | COBICISTAT; DARUNAVIR ETHANOLATE | TABLET, FOR SUSPENSION;ORAL | 90MG;EQ 600MG BASE | Yes | Yes |
| 002 | PREZCOBIX | DARUNAVIR AND COBICISTAT | TABLET, FOR SUSPENSION;ORAL | 675MG/150MG | No | No |
| 003 | PREZCOBIX | DARUNAVIR AND COBICISTAT | TABLET, FOR SUSPENSION;ORAL | 600MG/90MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85220 | ORIG | 2026-03-03 |