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Details for New Drug Application (NDA): 207620
NDA 207620 describes ENTRESTO, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ENTRESTO profile page.
The generic ingredient in ENTRESTO is sacubitril; valsartan. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
The generic ingredient in ENTRESTO is sacubitril; valsartan. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 207620
| Tradename: | ENTRESTO |
| Applicant: | Novartis Pharms Corp |
| Ingredient: | sacubitril; valsartan |
| Patents: | 6 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207620
| Mechanism of Action | Neprilysin Inhibitors Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 207620
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620 | NDA | Novartis Pharmaceuticals Corporation | 0078-0659 | N | 0078-0659-35 |
| ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620 | NDA | Novartis Pharmaceuticals Corporation | 0078-0659 | N | 0078-0659-67 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 24MG;26MG | ||||
| Approval Date: | Jul 7, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 7, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Nov 27, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Sign Up | Patent Expiration: | Jan 14, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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