Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201531
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Discontinued | None | No | No |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| IRBESARTAN | IRBESARTAN | 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 |
|---|---|---|---|---|---|---|---|
| 10/15/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/16/2025 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |