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FDA NDA · NDA218591

ENTRESTO

sacubitril and valsartan

Sponsor: NOVARTIS

APPLICATION
NDA218591
TYPE
NDA
ORIGINAL APPROVAL
2024-04-12
LATEST ACTION
2024-04-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE, PELLETS
MARKETING STATUS
Prescription

Products

ENTRESTO SPRINKLE · ReferencePrescription
SACUBITRIL 6MG, VALSARTAN 6MG · CAPSULE, PELLETS · ORAL
ENTRESTO SPRINKLE · ReferencePrescription
SACUBITRIL 15MG, VALSARTAN 16MG · CAPSULE, PELLETS · ORAL

Approval history

2024-04-12Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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