Composition
- Active ingredients
- PIRFENIDONE 801MG
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 · CapsuleANDA212731-001 · Prescription
- 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
- PIRFENIDONE 267MG · TabletANDA212730-001 · Prescription
- PIRFENIDONE 801MG · Tablet
At a glance
- Brand name
- Pirfenidone
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Accord Hlthcare
- Status
- Prescription
- FDA approval
- 25 Jan 2022
- Application
- ANDA212730-002