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Medicines · US (FDA)

FDA 2019

FDA

Ambrisentan

Approved 28 Mar 2019OralTablet

The FDA lists this product in 18 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: AMBRISENTAN 10MG

Strengths and forms

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

AMBRISENTAN 5MG · TabletANDA210715-001 · Prescription
AMBRISENTAN 10MG · TabletANDA210715-002 · Prescription
AMBRISENTAN 5MG · TabletANDA209509-001 · Discontinued
AMBRISENTAN 10MG · TabletANDA209509-002 · Discontinued
AMBRISENTAN 5MG · TabletANDA208441-001 · Prescription
AMBRISENTAN 10MG · TabletANDA208441-002 · Prescription
AMBRISENTAN 10MG · TabletANDA210058-002 · Prescription
AMBRISENTAN 5MG · TabletANDA210058-001 · Prescription
AMBRISENTAN 5MG · TabletANDA208252-001 · Prescription
AMBRISENTAN 10MG · TabletANDA208252-002 · Prescription
AMBRISENTAN 5MG · TabletANDA210701-001 · Prescription
AMBRISENTAN 10MG · TabletANDA210701-002 · Prescription
AMBRISENTAN 10MG · TabletThis page
AMBRISENTAN 5MG · Tablet

At a glance

Brand name: Ambrisentan
Route: Oral
Dosage form: Tablet
Applicant: Sun Pharm
Status: Prescription
FDA approval: 28 Mar 2019
Application: ANDA210784-002

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.

ANDA210784-001 · Discontinued

AMBRISENTAN 10MG · TabletANDA216531-002 · Prescription

AMBRISENTAN 5MG · TabletANDA216531-001 · Prescription

AMBRISENTAN 10MG · TabletANDA208354-002 · Prescription

AMBRISENTAN 5MG · TabletANDA208354-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA210784.

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.