Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090150
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET;ORAL | Discontinued | None | No | No |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;100MG | TABLET;ORAL | Discontinued | None | No | No |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/06/2010 | ORIG-2 | Approval |
Label is not available on this site. |
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| 08/11/2010 | 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 |
|---|---|---|---|---|---|
| 02/24/2017 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/01/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/01/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/01/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/01/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/05/2015 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |