Application 214012
- Type
- NDA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEQVIO | INCLISIRAN | INJECTABLE;INJECTION | 284MG/1.5ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0078-1000 | LEQVIO | inclisiran | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1000 | LEQVIO | inclisiran | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1000 | LEQVIO | inclisiran | Novartis Pharmaceuticals Corporation | NDA | Current |