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Orange Book product · Generic (ANDA)

PIRFENIDONE

PIRFENIDONE

Generic (ANDA)ANDA 212687DISCN APOTEX
View PIRFENIDONE familyOpen on FDA Orange Book

At a glance

Jun 09, 2023

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 09, 2023

    3 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PIRFENIDONE

Strength

267MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 212687

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PIRFENIDONE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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