Application 215039
- Type
- NDA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VIJOICE | ALPELISIB | TABLET; ORAL | 50MG | No | No |
| 002 | VIJOICE | ALPELISIB | TABLET; ORAL | 125MG | No | No |
| 003 | VIJOICE | ALPELISIB | TABLET; ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0078-1021 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1021 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1021 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1028 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1028 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1028 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1035 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1035 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1035 | VIJOICE | alpelisib | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82914 | SUPPL | 2025-07-24 |
| 82911 | SUPPL | 2025-07-23 |
| 78244 | SUPPL | 2024-04-25 |
| 72664 | ORIG | 2022-11-21 |
| 72654 | SUPPL | 2022-11-18 |
| 72651 | SUPPL | 2022-11-18 |
| 70727 | ORIG | 2022-04-07 |
| 70710 | ORIG | 2022-04-06 |