Application 205395
- Type
- NDA
- Sponsor
- JANSSEN PRODS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREZCOBIX | COBICISTAT; DARUNAVIR | TABLET;ORAL | 150MG;800MG | Yes | Yes |
| 002 | PREZCOBIX | COBICISTAT; DARUNAVIR ETHANOLATE | TABLET;ORAL | 150MG;EQ 675MG BASE | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-1723 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | A-S Medication Solutions | NDA | Current |
| 50090-1723 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | A-S Medication Solutions | NDA | Current |
| 59676-575 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | Janssen Products LP | NDA | Current |
| 59676-575 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | Janssen Products LP | NDA | Current |
| 59676-575 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | Janssen Products LP | NDA | Current |
| 59676-575 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | Janssen Products LP | NDA | Current |
| 59676-575 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | Janssen Products LP | NDA | Current |
| 59676-575 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | Janssen Products LP | NDA | Current |
| 59676-575 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | Janssen Products LP | NDA | Current |
| 70518-0714 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | REMEDYREPACK INC. | NDA | Current |
| 70518-0714 | PREZCOBIX | DARUNAVIR ETHANOLATE and COBICISTAT | REMEDYREPACK INC. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85274 | SUPPL | 2026-03-06 |
| 85205 | SUPPL | 2026-03-03 |
| 81711 | SUPPL | 2025-03-25 |
| 81703 | SUPPL | 2025-03-24 |
| 73936 | SUPPL | 2023-04-03 |
| 73922 | SUPPL | 2023-04-03 |
| 72456 | SUPPL | 2022-10-24 |
| 72436 | SUPPL | 2022-10-21 |
| 70777 | SUPPL | 2022-04-18 |
| 70770 | SUPPL | 2022-04-15 |
| 68202 | SUPPL | 2021-07-27 |
| 68190 | SUPPL | 2021-07-26 |
| 65755 | SUPPL | 2020-12-28 |
| 65720 | SUPPL | 2020-12-23 |
| 64186 | SUPPL | 2020-08-03 |
| 64172 | SUPPL | 2020-08-03 |
| 58944 | SUPPL | 2019-06-04 |
| 58886 | SUPPL | 2019-05-30 |
| 57540 | SUPPL | 2019-02-13 |
| 57375 | SUPPL | 2019-01-29 |
| 55445 | SUPPL | 2018-09-12 |
| 55423 | SUPPL | 2018-09-10 |
| 54457 | SUPPL | 2018-06-05 |
| 54437 | SUPPL | 2018-06-05 |
| 52428 | SUPPL | 2018-02-06 |
| 52427 | SUPPL | 2018-02-06 |
| 52125 | SUPPL | 2018-01-30 |
| 52124 | SUPPL | 2018-01-30 |
| 48723 | SUPPL | 2017-06-15 |
| 48720 | SUPPL | 2017-06-15 |
| 45523 | SUPPL | 2016-10-12 |
| 45414 | SUPPL | 2016-09-29 |
| 43486 | ORIG | 2016-06-15 |
| 24494 | ORIG | 2016-06-15 |
| 19642 | SUPPL | 2016-04-27 |
| 10443 | SUPPL | 2016-04-04 |
| 10442 | ORIG | 2015-02-02 |
| 40465 | ORIG | 2015-01-30 |