Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050715
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEORAL CYCLOSPORINE 25MG CAPSULE;ORAL Prescription AB1 Yes No
NEORAL CYCLOSPORINE 100MG CAPSULE;ORAL Prescription AB1 Yes Yes
NEORAL CYCLOSPORINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
07/14/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/31/2015 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050715s035,050716s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050715Orig1s035,050716Orig1s038ltr.pdf
05/02/2013 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050715s033,050716s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050715Orig1s033,050716Orig1s034ltr.pdf
08/30/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050715s029,050716s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050715Orig1s029,050716Orig1s030ltr.pdf
10/08/2009 SUPPL-28 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s028,050716s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s028ltr.pdf
09/24/2009 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s027,050716s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s027,050716s028ltr.pdf
08/01/2007 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050715s25,050716s26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050715s028, 050716s026ltr.pdf
03/06/2006 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050715s024,050716s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050715s024,050716s025ltr.pdf
07/19/2005 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050715s022,050716s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050715s022,050716s024ltr.pdf
02/06/2004 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf
02/06/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf
09/26/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/2002 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf
04/12/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/16/2002 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/12/2002 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf
06/30/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/21/1999 SUPPL-8 Labeling

Label is not available on this site.

10/04/2000 SUPPL-7 Labeling

Label is not available on this site.

03/30/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/19/1997 SUPPL-4 Labeling

Label is not available on this site.

10/11/1996 SUPPL-1 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
03/31/2015 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050715s035,050716s038lbl.pdf
05/02/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050715s033,050716s034lbl.pdf
08/30/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050715s029,050716s030lbl.pdf
10/08/2009 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s028,050716s029lbl.pdf
09/24/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s027,050716s028lbl.pdf
08/01/2007 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050715s25,050716s26lbl.pdf
03/06/2006 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050715s024,050716s025lbl.pdf
07/19/2005 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050715s022,050716s024lbl.pdf
02/06/2004 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf
02/06/2004 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf
06/12/2002 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf
06/12/2002 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf

NEORAL

CAPSULE;ORAL; 25MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 210721 APOTEX
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065110 IVAX SUB TEVA PHARMS
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065044 MAYNE PHARMA
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065017 SANDOZ
GENGRAF CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065003 ABBVIE
NEORAL CYCLOSPORINE 25MG CAPSULE;ORAL Prescription Yes AB1 050715 NOVARTIS

CAPSULE;ORAL; 100MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 210721 APOTEX
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065110 IVAX SUB TEVA PHARMS
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065044 MAYNE PHARMA
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065017 SANDOZ
GENGRAF CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065003 ABBVIE
NEORAL CYCLOSPORINE 100MG CAPSULE;ORAL Prescription Yes AB1 050715 NOVARTIS

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