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Medicines · US (FDA)

FDA 2023

FDA

Cyclosporine

Approved 12 Jan 2023EyeEmulsion

The FDA lists this product in 32 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: CYCLOSPORINE 0.05%

Strengths and forms

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

CYCLOSPORINE 0.05% · EmulsionANDA203880-001 · Prescription
CYCLOSPORINE 25MG · CapsuleANDA065017-002 · Prescription
CYCLOSPORINE 100MG · CapsuleANDA065017-001 · Prescription
CYCLOSPORINE 100MG · CapsuleANDA065044-001 · Prescription
CYCLOSPORINE 25MG · CapsuleANDA065044-002 · Prescription
CYCLOSPORINE 100MG/ML · SolutionANDA065078-001 · Prescription
CYCLOSPORINE 0.05% · EmulsionANDA205894-001 · Prescription
CYCLOSPORINE 0.05% · EmulsionANDA209811-001 · Prescription
CYCLOSPORINE 0.05% · EmulsionANDA211909-001 · Prescription
CYCLOSPORINE 25MG · CapsuleANDA219049-001 · Prescription
CYCLOSPORINE 100MG · CapsuleANDA219049-002 · Prescription
CYCLOSPORINE 50MG · CapsuleANDA216046-002 · Prescription
CYCLOSPORINE 100MG · CapsuleANDA216046-003 · Prescription

At a glance

Brand name: Cyclosporine
Route: Eye
Dosage form: Emulsion
Applicant: Apotex
Status: Discontinued
FDA approval: 12 Jan 2023
Application: ANDA207606-001

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.

CYCLOSPORINE 25MG · CapsuleANDA216046-001 · Prescription

CYCLOSPORINE 100MG/ML · SolutionANDA065025-001 · Discontinued

CYCLOSPORINE 25MG · CapsuleANDA065110-003 · Prescription

CYCLOSPORINE 50MG · CapsuleANDA065110-001 · Prescription

CYCLOSPORINE 100MG · CapsuleANDA065110-002 · Prescription

CYCLOSPORINE 50MG/ML · InjectableANDA065151-001 · Discontinued

CYCLOSPORINE 50MG · CapsuleANDA210721-002 · Prescription

CYCLOSPORINE 100MG · CapsuleANDA210721-003 · Prescription

CYCLOSPORINE 25MG · CapsuleANDA210721-001 · Prescription

CYCLOSPORINE 0.05% · EmulsionThis page

CYCLOSPORINE 50MG/ML · InjectableANDA065004-001 · Prescription

CYCLOSPORINE 100MG/ML · SolutionANDA065054-001 · Discontinued

CYCLOSPORINE 100MG/ML · SolutionANDA065133-001 · Discontinued

CYCLOSPORINE 0.05% · EmulsionANDA209064-001 · Prescription

CYCLOSPORINE 0.05% · EmulsionANDA219288-001 · Prescription

CYCLOSPORINE 25MG · CapsuleANDA065040-001 · Prescription

CYCLOSPORINE 100MG · CapsuleANDA065040-002 · Prescription

CYCLOSPORINE 100MG/ML · SolutionANDA065167-001 · Discontinued

CYCLOSPORINE 0.05% · EmulsionANDA211943-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA207606.

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.