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FDA NDA · NDA022535

ESBRIET

Sponsor: LEGACY

APPLICATION
NDA022535
TYPE
NDA
ORIGINAL APPROVAL
2014-10-15
LATEST ACTION
2023-02-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ESBRIET · ReferencePrescription
PIRFENIDONE 267MG · CAPSULE · ORAL

Approval history

2023-02-24Labeling · Supplement 16 · standard — Letter ↗AP
2022-02-11Labeling · Supplement 15 · standard — Label ↗AP
2019-07-31Labeling · Supplement 12 · standard — Letter ↗AP
2017-01-11Labeling · Supplement 5 · standard — Label ↗AP
2017-01-11Manufacturing (CMC) · Supplement 3 · standardAP
2016-06-08Manufacturing (CMC) · Supplement 2 · priorityAP
2015-09-24Manufacturing (CMC) · Supplement 1 · priority — Label ↗AP
2014-10-15Type 1 - New Molecular Entity · Original · priority — Review ↗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.

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