Application 050625
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SANDIMMUNE | CYCLOSPORINE | CAPSULE;ORAL | 25MG | Yes | No |
| 002 | SANDIMMUNE | CYCLOSPORINE | CAPSULE;ORAL | 100MG | Yes | Yes |
| 003 | SANDIMMUNE | CYCLOSPORINE | CAPSULE;ORAL | 50MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0240 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0240 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0240 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0240 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0240 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0240 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0241 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0241 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0241 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0241 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0241 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0241 | Sandimmune | cyclosporine | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85537 | SUPPL | 2026-03-26 |
| 85299 | SUPPL | 2026-03-09 |
| 75628 | SUPPL | 2023-09-29 |
| 75608 | SUPPL | 2023-09-29 |
| 70797 | SUPPL | 2022-04-20 |
| 70763 | SUPPL | 2022-04-14 |
| 30187 | SUPPL | 2015-04-02 |
| 17947 | SUPPL | 2015-04-01 |
| 39049 | SUPPL | 2013-05-09 |
| 30186 | SUPPL | 2013-05-07 |
| 7898 | SUPPL | 2012-09-05 |
| 17946 | SUPPL | 2012-08-31 |
| 17945 | SUPPL | 2010-05-07 |
| 30185 | SUPPL | 2010-05-06 |
| 30184 | SUPPL | 2009-11-10 |
| 17944 | SUPPL | 2009-10-14 |
| 30183 | SUPPL | 2006-03-23 |
| 17943 | SUPPL | 2006-03-10 |
| 17942 | SUPPL | 2005-07-26 |
| 7897 | SUPPL | 2005-07-26 |
| 30182 | SUPPL | 2004-06-17 |
| 7896 | SUPPL | 2004-06-17 |
| 7895 | SUPPL | 2004-06-17 |
| 39048 | SUPPL | 2004-03-03 |
| 17941 | SUPPL | 2004-03-03 |
| 30181 | SUPPL | 2004-02-27 |
| 39047 | SUPPL | 2003-03-05 |
| 17940 | SUPPL | 2003-03-05 |