Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090201
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Discontinued | None | No | No |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| IRBESARTAN | IRBESARTAN | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/15/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/03/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/08/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/09/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |