Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065054
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| 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 |
|---|---|---|---|---|---|---|---|
| 12/18/2001 | 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 |
|---|---|---|---|---|---|
| 01/20/2015 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/16/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/05/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/02/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/14/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/03/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 05/03/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |