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Medicines · US (FDA)

FDA 2016

FDA

Dutasteride

Approved 17 Mar 2016OralCapsule

The FDA lists this product in 19 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: DUTASTERIDE 0.5MG

Strengths and forms

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

DUTASTERIDE 0.5MG · CapsuleANDA203241-001 · Discontinued
DUTASTERIDE 0.5MG · CapsuleANDA206574-001 · Prescription
DUTASTERIDE 0.5MG · CapsuleANDA207935-001 · Discontinued
DUTASTERIDE 0.5MG · CapsuleANDA209909-001 · Prescription
DUTASTERIDE 0.5MG · CapsuleANDA208227-001 · Discontinued
DUTASTERIDE 0.5MG · CapsuleANDA202808-001 · Discontinued
DUTASTERIDE 0.5MG · CapsuleANDA204373-001 · Prescription
DUTASTERIDE 0.5MG · CapsuleANDA202421-001 · Discontinued
DUTASTERIDE 0.5MG · CapsuleANDA202660-001 · Prescription
DUTASTERIDE 0.5MG · CapsuleANDA090095-001 · Prescription
DUTASTERIDE 0.5MG · CapsuleANDA204262-001 · Prescription
DUTASTERIDE 0.5MG · CapsuleANDA204292-001 · Discontinued
DUTASTERIDE 0.5MG · CapsuleThis page
DUTASTERIDE 0.5MG · Capsule

At a glance

Brand name: Dutasteride
Route: Oral
Dosage form: Capsule
Applicant: Acella
Status: Prescription
FDA approval: 17 Mar 2016
Application: ANDA206373-001

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.

ANDA203118-001 · Prescription

DUTASTERIDE 0.5MG · CapsuleANDA202204-001 · Discontinued

DUTASTERIDE 0.5MG · CapsuleANDA202530-001 · Discontinued

DUTASTERIDE 0.5MG · CapsuleANDA200899-001 · Prescription

DUTASTERIDE 0.5MG · CapsuleANDA204376-001 · Prescription

DUTASTERIDE 0.5MG · CapsuleANDA204705-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA206373.

Open Drugs@FDA

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.