Application 207620
- Type
- NDA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENTRESTO | SACUBITRIL; VALSARTAN | TABLET;ORAL | 24MG;26MG | Yes | No |
| 002 | ENTRESTO | SACUBITRIL; VALSARTAN | TABLET;ORAL | 49MG;51MG | Yes | No |
| 003 | ENTRESTO | SACUBITRIL; VALSARTAN | TABLET;ORAL | 97MG;103MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0078-0659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0696 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0696 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0696 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0696 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0696 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0696 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0696 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0696 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-9659 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-9777 | ENTRESTO | Sacubitril and Valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |