Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202118
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Discontinued | None | No | No |
| DARUNAVIR | DARUNAVIR | 150MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| DARUNAVIR | DARUNAVIR | 400MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/21/2017 | ORIG-2 | Tentative Approval | Not Applicable |
Label is not available on this site. |
|||
| 11/21/2017 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202118Orig1s000ApprovandTAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/21/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2023 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |