Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050625
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
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
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

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