Application 050573
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SANDIMMUNE | CYCLOSPORINE | INJECTABLE;INJECTION | 50MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0109 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0109 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0109 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0109 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0109 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0109 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85331 | SUPPL | 2026-03-12 |
| 85297 | SUPPL | 2026-03-09 |
| 75626 | SUPPL | 2023-09-30 |
| 75606 | SUPPL | 2023-09-29 |
| 30090 | SUPPL | 2015-04-02 |
| 17885 | SUPPL | 2015-04-01 |
| 38986 | SUPPL | 2013-05-09 |
| 30089 | SUPPL | 2013-05-07 |
| 7828 | SUPPL | 2012-09-05 |
| 17884 | SUPPL | 2012-08-31 |
| 17883 | SUPPL | 2010-05-07 |
| 7827 | SUPPL | 2010-05-06 |
| 7826 | SUPPL | 2009-11-10 |
| 17882 | SUPPL | 2009-10-14 |
| 7825 | SUPPL | 2006-03-23 |
| 17881 | SUPPL | 2006-03-10 |
| 17880 | SUPPL | 2005-07-26 |
| 7824 | SUPPL | 2005-07-26 |
| 7822 | SUPPL | 2004-06-17 |
| 7821 | SUPPL | 2004-06-17 |
| 38985 | SUPPL | 2004-03-03 |
| 17879 | SUPPL | 2004-03-03 |
| 30088 | SUPPL | 2004-02-27 |
| 7823 | SUPPL | 2004-02-27 |
| 38984 | SUPPL | 2003-03-05 |
| 17878 | SUPPL | 2003-03-05 |