Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202554
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LISINOPRIL | LISINOPRIL | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/2013 | 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 |
|---|---|---|---|---|---|
| 09/13/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2016 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |