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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 218591


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NDA 218591 describes ENTRESTO SPRINKLE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ENTRESTO SPRINKLE profile page.

The generic ingredient in ENTRESTO SPRINKLE 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 218591
Tradename:ENTRESTO SPRINKLE
Applicant:Novartis
Ingredient:sacubitril; valsartan
Patents:4
Pharmacology for NDA: 218591
Suppliers and Packaging for NDA: 218591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTRESTO SPRINKLE sacubitril; valsartan CAPSULE, PELLETS;ORAL 218591 NDA Novartis Pharmaceuticals Corporation 0078-1231 0078-1231-20 60 PELLET in 1 BOTTLE (0078-1231-20)
ENTRESTO SPRINKLE sacubitril; valsartan CAPSULE, PELLETS;ORAL 218591 NDA Novartis Pharmaceuticals Corporation 0078-1238 0078-1238-20 60 PELLET in 1 BOTTLE (0078-1238-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, PELLETS;ORALStrength6MG;6MG
Approval Date:Apr 12, 2024TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 2, 2037Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HEART FAILURE WITH ORAL PELLETS
Patent:⤷  Sign UpPatent Expiration:Jan 15, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 27, 2027Product Flag?YSubstance Flag?YDelist Request?

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