Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050715
Company: NOVARTIS
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| NEORAL | CYCLOSPORINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 09/26/2023 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050715s041,050716s041,050735s003,050736s001,050737s003,050738s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050715Orig1s041,050716Orig1s041,050735Orig1s003,050736Orig1s001,050737Orig1s003,050738Orig1s001ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 09/26/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050715s041,050716s041,050735s003,050736s001,050737s003,050738s001lbl.pdf | |
| 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 | 065044 | DR REDDYS LABS SA |
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB1 | 065110 | IVAX SUB TEVA PHARMS |
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB1 | 065017 | SANDOZ |
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB1 | 216046 | STRIDES PHARMA |
| 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 | 065044 | DR REDDYS LABS SA |
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 065110 | IVAX SUB TEVA PHARMS |
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 065017 | SANDOZ |
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 216046 | STRIDES PHARMA |
| GENGRAF | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 065003 | ABBVIE |
| NEORAL | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB1 | 050715 | NOVARTIS |