Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200290
Company: IPCA LABS LTD
Company: IPCA LABS LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2013 | 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 |
|---|---|---|---|---|---|
| 08/18/2025 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/03/2019 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/03/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |