Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208695
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Discontinued | None | No | No |
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/06/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |