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Medicines · US (FDA)

FDA 2022

Triazole and tetrazole derivatives

Posaconazole

Approved 10 May 2022OralTablet, 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 releaseThis page
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 release

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.

ANDA216626-001 · Prescription

POSACONAZOLE 100MG · Tablet, delayed releaseANDA212500-001 · Prescription

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

POSACONAZOLE 100MG · Tablet, delayed releaseANDA217720-001 · Prescription

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 ANDA212226.

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.

At a glance

Brand name: Posaconazole
Drug class: Triazole and tetrazole derivatives
Route: Oral
Dosage form: Tablet, delayed release
Applicant: Specgx LLC
Status: Prescription
FDA approval: 10 May 2022
Application: ANDA212226-001
RxCUI: 282446