Pirfenidone

ANDA 212731, held by Accord Hlthcare. Pirfenidone.

As of Nov 14, 2026, ANDA 212731 (Pirfenidone), held by Accord Hlthcare, was first approved by FDA on Jan 20, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 20, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 20, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pirfenidone267MG · capsule;oral	Pirfenidone	Rx

All 3 submissions, including labeling and manufacturing supplements


Feb 4, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Feb 28, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Jan 20, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 212731
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters