Composition
- Active ingredients
- PIRFENIDONE 267MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- PIRFENIDONE 267MG · CapsuleThis page
- PIRFENIDONE 801MG · TabletNDA208780-003 · Prescription
- PIRFENIDONE 267MG · TabletNDA208780-001 · Prescription
- PIRFENIDONE 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA208780-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA022535.
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
- Esbriet
- Active substance
- pirfenidone
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Legacy Pharma
- Status
- Prescription
- FDA approval
- 15 Oct 2014
- Application
- NDA022535-001