Details for New Drug Application (NDA): 207620
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The generic ingredient in ENTRESTO is sacubitril; valsartan. There are eleven drug master file entries for this compound. Two suppliers are 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: | 8 |
Pharmacology for NDA: 207620
Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
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 | 0078-0659-20 | 60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20) |
ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620 | NDA | Novartis Pharmaceuticals Corporation | 0078-0659 | 0078-0659-67 | 180 TABLET, FILM COATED in 1 BOTTLE (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: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Feb 16, 2024 | ||||||||
Regulatory Exclusivity Use: | LABELING REVISIONS RELATED TO CLINICAL STUDIES | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 9, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 22, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION |
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