Application 050574
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SANDIMMUNE | CYCLOSPORINE | SOLUTION;ORAL | 100MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0110 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0110 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0110 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0110 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0110 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0110 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85538 | SUPPL | 2026-03-26 |
| 85298 | SUPPL | 2026-03-09 |
| 75627 | SUPPL | 2023-09-29 |
| 75607 | SUPPL | 2023-09-29 |
| 30100 | SUPPL | 2015-04-02 |
| 17887 | SUPPL | 2015-04-01 |
| 38995 | SUPPL | 2013-05-09 |
| 30099 | SUPPL | 2013-05-07 |
| 30098 | SUPPL | 2012-09-05 |
| 38994 | SUPPL | 2012-08-31 |
| 38993 | SUPPL | 2010-05-07 |
| 30097 | SUPPL | 2010-05-06 |
| 30096 | SUPPL | 2009-11-10 |
| 38992 | SUPPL | 2009-10-14 |
| 30095 | SUPPL | 2006-03-23 |
| 38991 | SUPPL | 2006-03-10 |
| 17886 | SUPPL | 2005-07-26 |
| 7829 | SUPPL | 2005-07-26 |
| 30092 | SUPPL | 2004-06-17 |
| 30091 | SUPPL | 2004-06-17 |
| 38990 | SUPPL | 2004-03-03 |
| 38989 | SUPPL | 2004-03-03 |
| 30094 | SUPPL | 2004-02-27 |
| 30093 | SUPPL | 2004-02-27 |
| 38988 | SUPPL | 2003-03-05 |
| 38987 | SUPPL | 2003-03-05 |