Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207018
Company: UNICHEM
Company: UNICHEM
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/19/2017 | 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 |
|---|---|---|---|---|---|
| 11/28/2025 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/08/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/08/2021 | SUPPL-4 | Labeling, Labeling-Package Insert |
Label is not available on this site. |
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| 05/21/2021 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 05/21/2021 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |