Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065151
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 10/07/2003 | 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 |
|---|---|---|---|---|---|
| 06/30/2015 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/24/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |