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Medicines · US (FDA)

FDA 2025

FDA

Sacubitril and Valsartan

Approved 13 Jan 2025OralTablet

The FDA lists this product in 42 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: SACUBITRIL 24MG; VALSARTAN 26MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213604-002 · Prescription
SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213604-003 · Prescription
SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213604-001 · Prescription
SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213676-003 · Prescription
SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213676-001 · Prescription
SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213676-002 · Prescription
SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213611-002 · Prescription
SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213611-003 · Prescription
SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213611-001 · Prescription
SACUBITRIL 24MG; VALSARTAN 26MG · Tablet

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA213605-001 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213605-002 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213605-003 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213680-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213680-001 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213680-002 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213748-002 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213748-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213748-001 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213808-001 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213808-002 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213808-003 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213627-002 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213627-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletThis page

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213764-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213764-001 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213764-002 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213668-002 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213668-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213668-001 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213719-002 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213719-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213719-001 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA219983-002 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA219983-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA219983-001 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213682-002 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213682-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213682-001 · Prescription

SACUBITRIL 97MG; VALSARTAN 103MG · TabletANDA213728-003 · Prescription

SACUBITRIL 24MG; VALSARTAN 26MG · TabletANDA213728-001 · Prescription

SACUBITRIL 49MG; VALSARTAN 51MG · TabletANDA213728-002 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA213627.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Sacubitril and Valsartan
Active substance: sacubitril
Route: Oral
Dosage form: Tablet
Applicant: DR Reddys
Status: Prescription
FDA approval: 13 Jan 2025
Application: ANDA213627-001