Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SANDIMMUNE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | AB2 | Yes | No |
SANDIMMUNE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | AB2 | Yes | Yes |
SANDIMMUNE | CYCLOSPORINE | 50MG | CAPSULE;ORAL | Prescription | BX | Yes | 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 |
---|---|---|---|---|---|---|---|
03/02/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/28/2023 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050573s044,050574s057,050625s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050573Orig1s044;050574Orig1s057;050625Orig1s061ltr.pdf | |
03/16/2022 | SUPPL-60 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050625Orig1s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050625Orig1s060ltr.pdf | |
01/06/2016 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/31/2015 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050573Orig1s041,050574Orig1s051,050625Orig1s055ltr.pdf | |
05/03/2013 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574Orig1s047,050625Orig1s053ltr.pdf | |
08/30/2012 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574Orig1s043,050625Orig1s049ltr.pdf | |
04/30/2010 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,050574s042ltr.pdf | |
10/08/2009 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,050625s047ltr.pdf | |
07/20/2007 | SUPPL-45 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2006 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,050625s044ltr.pdf | |
07/19/2005 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,050625s043ltr.pdf | |
02/06/2004 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf | |
02/06/2004 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf | |
04/12/2002 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/16/2002 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/14/2003 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf | |
02/14/2003 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf | |
06/30/2000 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/21/1999 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
10/04/2000 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
03/30/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/15/1996 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/09/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
11/21/1995 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
11/21/1995 | SUPPL-21 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
01/13/1995 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/10/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
03/07/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/09/1994 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/09/1994 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/17/1993 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/02/1992 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/19/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/23/1992 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/21/1992 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/10/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
12/30/1992 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
12/30/1992 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/24/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
11/21/1991 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/28/2023 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050573s044,050574s057,050625s061lbl.pdf | |
03/16/2022 | SUPPL-60 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050625Orig1s060lbl.pdf | |
03/31/2015 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf | |
05/03/2013 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf | |
08/30/2012 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf | |
04/30/2010 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf | |
10/08/2009 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf | |
03/06/2006 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf | |
07/19/2005 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf | |
02/06/2004 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf | |
02/06/2004 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf | |
02/14/2003 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf | |
02/14/2003 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf |
SANDIMMUNE
CAPSULE;ORAL; 25MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB2 | 065040 | APOTEX |
SANDIMMUNE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 050625 | NOVARTIS |
CAPSULE;ORAL; 100MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB2 | 065040 | APOTEX |
SANDIMMUNE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 050625 | NOVARTIS |