Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090351
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Discontinued | None | No | No |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Discontinued | None | No | No |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 25MG;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 |
|---|---|---|---|---|---|---|---|
| 06/08/2017 | ORIG-2 | Approval |
Label is not available on this site. |
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| 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 |
|---|---|---|---|---|---|
| 11/28/2025 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/05/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/05/2022 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/04/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/04/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/07/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/07/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/02/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |