Application 050737
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 25MG | No | No |
| 002 | NEORAL | CYCLOSPORINE | CAPSULE; ORAL | 100MG | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| RESTASIS | CYCLOSPORINE | A-S Medication Solutions | ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03 | 2024-05-24 | Warnings, Adverse reactions | CYCLOSPORINE |
| Cyclosporine | CYCLOSPORINE | American Health Packaging | a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b | 2024-05-13 | Boxed warning, Warnings, Adverse reactions | CYCLOSPORINE |
| Cyclosporine Modified | CYCLOSPORINE | Teva Pharmaceuticals USA, Inc. | 2de1e8b1-625f-43ce-a1d5-d543be208b11 | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | CYCLOSPORINE |
| Cyclosporine | CYCLOSPORINE | Teva Pharmaceuticals, Inc. | cc64c1e3-19f5-4bf6-a08d-a9725004c97f | 2024-03-01 | Warnings, Adverse reactions | CYCLOSPORINE |
| Cyclosporine | CYCLOSPORINE | Mylan Pharmaceuticals Inc. | da3fa070-b512-4568-871a-dc8d5a949d13 | 2022-01-20 | Warnings, Adverse reactions | CYCLOSPORINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.