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Medicines · US (FDA)

FDA 2022

Other immunosuppressants

Pirfenidone

Approved 20 Jan 2022OralCapsule

The FDA lists this product in 42 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: PIRFENIDONE 267MG

Strengths and forms

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

PIRFENIDONE 267MG · CapsuleANDA212569-001 · Prescription
PIRFENIDONE 801MG · TabletANDA212596-002 · Prescription
PIRFENIDONE 267MG · TabletANDA212596-001 · Prescription
PIRFENIDONE 267MG · CapsuleThis page
PIRFENIDONE 267MG · TabletANDA212615-001 · Tentative approval
PIRFENIDONE 801MG · TabletANDA212615-002 · Tentative approval
PIRFENIDONE 267MG · TabletANDA212674-001 · Prescription
PIRFENIDONE 801MG · TabletANDA212674-002 · Prescription
PIRFENIDONE 267MG · CapsuleANDA212687-001 · Discontinued
PIRFENIDONE 801MG · TabletANDA212570-002 · Prescription
PIRFENIDONE 267MG · TabletANDA212570-001 · Prescription
PIRFENIDONE 267MG · CapsuleANDA212724-001 · Prescription

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.

PIRFENIDONE 267MG · TabletANDA212730-001 · Prescription

PIRFENIDONE 801MG · TabletANDA212730-002 · Prescription

PIRFENIDONE 267MG · CapsuleANDA212077-001 · Prescription

PIRFENIDONE 267MG · TabletANDA212560-001 · Prescription

PIRFENIDONE 801MG · TabletANDA212560-002 · Prescription

PIRFENIDONE 801MG · TabletANDA212680-002 · Prescription

PIRFENIDONE 534MG · TabletANDA212680-003 · Prescription

PIRFENIDONE 267MG · TabletANDA212680-001 · Prescription

PIRFENIDONE 267MG · CapsuleANDA212597-001 · Prescription

PIRFENIDONE 267MG · CapsuleANDA212600-001 · Prescription

PIRFENIDONE 801MG · TabletANDA212722-003 · Prescription

PIRFENIDONE 267MG · TabletANDA212722-001 · Prescription

PIRFENIDONE 534MG · TabletANDA212722-002 · Prescription

PIRFENIDONE 267MG · CapsuleANDA212404-001 · Discontinued

PIRFENIDONE 801MG · TabletANDA212709-002 · Prescription

PIRFENIDONE 267MG · TabletANDA212709-001 · Prescription

PIRFENIDONE 267MG · TabletANDA212759-001 · Prescription

PIRFENIDONE 801MG · TabletANDA212759-002 · Prescription

PIRFENIDONE 267MG · CapsuleANDA212748-001 · Prescription

PIRFENIDONE 267MG · TabletANDA212078-001 · Prescription

PIRFENIDONE 801MG · TabletANDA212078-002 · Prescription

PIRFENIDONE 267MG · TabletANDA212708-001 · Prescription

PIRFENIDONE 801MG · TabletANDA212708-002 · Prescription

PIRFENIDONE 534MG · TabletANDA212747-002 · Prescription

PIRFENIDONE 801MG · TabletANDA212747-003 · Prescription

PIRFENIDONE 267MG · TabletANDA212747-001 · Prescription

PIRFENIDONE 801MG · TabletANDA212403-002 · Discontinued

PIRFENIDONE 267MG · TabletANDA212403-001 · Discontinued

PIRFENIDONE 801MG · TabletANDA212772-002 · Prescription

PIRFENIDONE 267MG · TabletANDA212772-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA212731.

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: Pirfenidone
Drug class: Other immunosuppressants
Route: Oral
Dosage form: Capsule
Applicant: Accord Hlthcare
Status: Prescription
FDA approval: 20 Jan 2022
Application: ANDA212731-001
RxCUI: 1592254