Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065167
Company: PHARM ASSOC
Company: PHARM ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 100MG/ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 01/05/2005 | 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 |
|---|---|---|---|---|---|
| 07/27/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2010 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2009 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/20/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 11/29/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |