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Medicines · US (FDA)

FDA 2004

FDA

Itraconazole

Approved 28 May 2004OralCapsule

The FDA lists this product in 14 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: ITRACONAZOLE 100MG

Strengths and forms

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

ITRACONAZOLE 10MG/ML · SolutionANDA212239-001 · Prescription
ITRACONAZOLE 10MG/ML · SolutionANDA205573-001 · Prescription
ITRACONAZOLE 100MG · CapsuleANDA205724-001 · Prescription
ITRACONAZOLE 100MG · CapsuleANDA204672-001 · Prescription
ITRACONAZOLE 100MG · CapsuleANDA205080-001 · Prescription
ITRACONAZOLE 100MG · CapsuleANDA206410-001 · Discontinued
ITRACONAZOLE 100MG · CapsuleANDA208591-001 · Prescription
ITRACONAZOLE 100MG · CapsuleThis page
ITRACONAZOLE 100MG · CapsuleANDA209460-001 · Prescription
ITRACONAZOLE 100MG · CapsuleANDA200463-001 · Discontinued
ITRACONAZOLE 100MG · CapsuleANDA205991-001 · Discontinued
ITRACONAZOLE 10MG/ML · SolutionANDA208481-001 · Discontinued
ITRACONAZOLE 100MG · CapsuleANDA203445-001 · Discontinued

At a glance

Brand name: Itraconazole
Route: Oral
Dosage form: Capsule
Applicant: Sandoz
Status: Prescription
FDA approval: 28 May 2004
Application: ANDA076104-001

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.

ITRACONAZOLE 100MG · CapsuleANDA206741-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA076104.

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.