Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077459
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 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-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 |
|---|---|---|---|---|---|
| 01/16/2026 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/16/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/30/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/10/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/13/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/26/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/19/2013 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/19/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/15/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/16/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |