Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065025
Company: ABBVIE
Company: ABBVIE
| 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 |
|---|---|---|---|---|---|---|---|
| 03/03/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65025_Cyclosporine.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/04/2025 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/04/2025 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/06/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2013 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2010 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2009 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 07/13/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/26/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/07/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/01/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/05/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/26/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/14/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-3 | Bioequivalence |
Label is not available on this site. |
||
| 08/09/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/05/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |