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Medicines · US (FDA)

FDA 2025

FDA

Posaconazole

Approved 23 Apr 2025OralTablet, delayed release

The FDA lists this product in 21 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: POSACONAZOLE 100MG

Strengths and forms

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

POSACONAZOLE 100MG · Tablet, delayed releaseANDA212411-001 · Prescription
POSACONAZOLE 300MG/16.7ML (18MG/ML) · SolutionANDA217553-001 · Prescription
POSACONAZOLE 300MG/16.7ML (18MG/ML) · SolutionANDA211500-001 · Prescription
POSACONAZOLE 100MG · Tablet, delayed releaseANDA212226-001 · Prescription
POSACONAZOLE 100MG · Tablet, delayed releaseANDA207355-001 · Discontinued
POSACONAZOLE 300MG/16.7ML (18MG/ML) · SolutionANDA208768-001 · Prescription
POSACONAZOLE 300MG/16.7ML (18MG/ML) · SolutionANDA219057-001 · Prescription
POSACONAZOLE 100MG · Tablet, delayed releaseANDA216488-001 · Prescription
POSACONAZOLE 100MG · Tablet, delayed releaseANDA217119-001 · Prescription
POSACONAZOLE 18MG · InjectionANDA217709-001 · Tentative approval
POSACONAZOLE 100MG · Tablet, delayed releaseANDA216626-001 · Prescription
POSACONAZOLE 100MG · Tablet, delayed releaseANDA212500-001 · Prescription

At a glance

Brand name: Posaconazole
Route: Oral
Dosage form: Tablet, delayed release
Applicant: Qilu Pharm Hainan
Status: Prescription
FDA approval: 23 Apr 2025
Application: ANDA217720-001

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.

POSACONAZOLE 100MG · Tablet, delayed releaseANDA214321-001 · Prescription

POSACONAZOLE 100MG · Tablet, delayed releaseThis page

POSACONAZOLE 100MG · Tablet, delayed releaseANDA218434-001 · Prescription

POSACONAZOLE 100MG · Tablet, delayed releaseANDA213454-001 · Prescription

POSACONAZOLE 100MG · Tablet, delayed releaseANDA214476-001 · Prescription

POSACONAZOLE 300MG/16.7ML (18MG/ML) · SolutionANDA214842-001 · Prescription

POSACONAZOLE 40MG/ML · SuspensionANDA208773-001 · Prescription

POSACONAZOLE 300MG/16.7ML (18MG/ML) · SolutionANDA209983-001 · Prescription

POSACONAZOLE 100MG · Tablet, delayed releaseANDA216326-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA217720.

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.