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Medicines · US (FDA)

FDA 2015

FDA

Dutasteride

Approved 23 Nov 2015OralCapsule

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 · CapsuleANDA206373-001 · Prescription
DUTASTERIDE 0.5MG · Capsule

At a glance

Brand name: Dutasteride
Route: Oral
Dosage form: Capsule
Applicant: Hikma
Status: Discontinued
FDA approval: 23 Nov 2015
Application: ANDA202204-001

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 · CapsuleThis page

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 ANDA202204.

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.