Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050573
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SANDIMMUNE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/14/1983 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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-44 | 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 | |
| 03/31/2015 | SUPPL-41 | 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 | |
| 11/02/2015 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/2013 | SUPPL-39 | 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 | |
| 02/07/2013 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/2012 | SUPPL-35 | 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-34 | 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-33 | Labeling-Medication Guide |
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 | |
| 03/06/2006 | SUPPL-31 | 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-30 | 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-28 | 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-27 | 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-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/2002 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2003 | SUPPL-23 | 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-21 | 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 | |
| 03/09/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/2001 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/10/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/07/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1994 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/09/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1993 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/1992 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/19/1993 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/19/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
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-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050573s044,050574s057,050625s061lbl.pdf | |
| 03/31/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf | |
| 05/03/2013 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf | |
| 08/30/2012 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf | |
| 04/30/2010 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf | |
| 10/08/2009 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf | |
| 03/06/2006 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf | |
| 07/19/2005 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf | |
| 02/06/2004 | SUPPL-28 | 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-27 | 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-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf | |
| 02/14/2003 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf |
SANDIMMUNE
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065004 | HIKMA |
| CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065151 | PADAGIS US |
| SANDIMMUNE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050573 | NOVARTIS |