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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218591

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ENTRESTO SPRINKLE (SACUBITRIL; VALSARTAN)
6MG;6MG
Marketing Status: Prescription
Active Ingredient: SACUBITRIL; VALSARTAN
Proprietary Name: ENTRESTO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, PELLETS; ORAL
Strength: 6MG;6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218591
Product Number: 001
Approval Date: Apr 12, 2024
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
ENTRESTO SPRINKLE (SACUBITRIL; VALSARTAN)
15MG;16MG
Marketing Status: Prescription
Active Ingredient: SACUBITRIL; VALSARTAN
Proprietary Name: ENTRESTO SPRINKLE
Dosage Form; Route of Administration: CAPSULE, PELLETS; ORAL
Strength: 15MG;16MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218591
Product Number: 002
Approval Date: Apr 12, 2024
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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