Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220092
Company: JANSSEN PRODS
Company: JANSSEN PRODS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREZCOBIX | DARUNAVIR AND COBICISTAT | 675MG/150MG | TABLET, FOR SUSPENSION;ORAL | Prescription | None | No | No |
| PREZCOBIX | DARUNAVIR AND COBICISTAT | 600MG/90MG | TABLET, FOR SUSPENSION;ORAL | Prescription | None | No | No |
| PREZCOBIX PED | COBICISTAT; DARUNAVIR ETHANOLATE | 90MG;EQ 600MG BASE | TABLET, FOR SUSPENSION;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/27/2026 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220092Orig1s000ltr.pdf |