Application 215358
- Type
- NDA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SCEMBLIX | ASCIMINIB | TABLET;ORAL | 20MG | No | No |
| 002 | SCEMBLIX | ASCIMINIB | TABLET;ORAL | 40MG | No | No |
| 003 | SCEMBLIX | ASCIMINIB HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0078-1091 | SCEMBLIX | asciminib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1091 | SCEMBLIX | asciminib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1091 | SCEMBLIX | asciminib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1098 | SCEMBLIX | asciminib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1098 | SCEMBLIX | asciminib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1098 | SCEMBLIX | asciminib | Novartis Pharmaceuticals Corporation | NDA | Current |