← FDA DRUG APPROVALS

FDA NDA · NDA207620

ENTRESTO

sacubitril and valsartan

Sponsor: NOVARTIS PHARMS CORP

APPLICATION
NDA207620
TYPE
NDA
ORIGINAL APPROVAL
2015-07-07
LATEST ACTION
2024-04-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ENTRESTO · ReferencePrescription
SACUBITRIL 97MG, VALSARTAN 103MG · TABLET · ORAL
ENTRESTO · ReferencePrescription
SACUBITRIL 24MG, VALSARTAN 26MG · TABLET · ORAL
ENTRESTO · ReferencePrescription
SACUBITRIL 49MG, VALSARTAN 51MG · TABLET · ORAL

Approval history

2024-04-12Efficacy · Supplement 25 · standard — Label ↗AP
2023-10-18Manufacturing (CMC) · Supplement 24 — Label ↗AP
2021-02-16Efficacy · Supplement 18 · standard — Label ↗AP
2019-10-01Efficacy · Supplement 13 · priority — Label ↗AP
2017-11-22Labeling · Supplement 8 · standard — Label ↗AP
2016-12-21Manufacturing (CMC) · Supplement 4 · standardAP
2016-05-11Manufacturing (CMC) · Supplement 2 · priorityAP
2016-02-12Manufacturing (CMC) · Supplement 1 · priorityAP
2015-07-07Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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