← FDA DRUG APPROVALS

FDA NDA · NDA208780

ESBRIET

pirfenidone

Sponsor: LEGACY

APPLICATION
NDA208780
TYPE
NDA
ORIGINAL APPROVAL
2017-01-11
LATEST ACTION
2023-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

ESBRIET · ReferencePrescription
PIRFENIDONE 801MG · TABLET · ORAL
ESBRIET · ReferencePrescription
PIRFENIDONE 267MG · TABLET · ORAL
ESBRIET · ReferenceDiscontinued
PIRFENIDONE 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-02-24Labeling · Supplement 7 · standard — Letter ↗AP
2022-02-11Labeling · Supplement 5 · standard — Label ↗AP
2019-07-31Labeling · Supplement 2 · standard — Letter ↗AP
2017-01-11Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →