FdaApplication
NDA 220092
Identifiers
- fda_app_no: NDA220092
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PRODUCTS LP |
| application_type | NDA |
| approval_date | 2026-02-27 |
Revenue by product
PREZCOBIX
| Period | Revenue |
|---|---|
| Q2 2026 | $372.0M* |
| Q1 2026 | $443.0M* |
| Q4 2025 | $383.0M* |
| Q3 2025 | $397.0M* |
| Q2 2025 | $396.0M* |
| Q1 2025 | $403.0M* |
| Q4 2024 | $407.0M* |
| Q3 2024 | $449.0M* |
| Q2 2024 | $438.0M* |
| Q1 2024 | $418.0M* |
| Q4 2023 | $439.0M* |
| Q3 2023 | $447.0M* |
| Q2 2023 | $491.0M* |
| Q1 2023 | $477.0M* |
| Q4 2022 | $493.0M* |
| Q3 2022 | $485.0M* |
| Q2 2022 | $464.0M* |
| Q1 2022 | $501.0M* |
| Q4 2021 | $515.0M* |
| Q3 2021 | $517.0M* |
| Q2 2021 | $505.0M* |
| Q1 2021 | $546.0M* |
| Q4 2020 | $569.0M* |
| Q3 2020 | $526.0M* |
| Q2 2020 | $510.0M* |
| Q1 2020 | $579.0M* |
| Q4 2019 | $544.0M* |
| Q3 2019 | $508.0M* |
| Q2 2019 | $535.0M* |
| Q1 2019 | $523.0M* |
| Q4 2018 | $495.0M* |
| Q3 2018 | $490.0M* |
| Q2 2018 | $492.0M* |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PREZCOBIX | DARUNAVIR AND COBICISTAT | 675MG/150MG | TABLET, FOR SUSPENSION;ORAL |
| PREZCOBIX | DARUNAVIR AND COBICISTAT | 600MG/90MG | TABLET, FOR SUSPENSION;ORAL |
| PREZCOBIX PED | COBICISTAT; DARUNAVIR ETHANOLATE | 90MG;EQ 600MG BASE | TABLET, FOR SUSPENSION;ORAL |
3 products