Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202079
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET;ORAL | Discontinued | None | No | No |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET;ORAL | Discontinued | None | No | No |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET;ORAL | Discontinued | None | No | No |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/10/2014 | 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 |
|---|---|---|---|---|---|
| 02/12/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |