Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077969
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 07/20/2016 | ORIG-2 | Approval |
Label is not available on this site. |
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| 09/27/2012 | 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 |
|---|---|---|---|---|---|
| 10/10/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/10/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/23/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/27/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/18/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/30/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |