← FDA Drug Approvals (Drugs@FDA)

PIRFENIDONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACCORD HLTHCARE · Approved 2022-01-25

Drug application

FDA Application #

ANDA212730

Application type

Abbreviated New Drug Application (Generic)

Brand name

PIRFENIDONE

Generic name

PIRFENIDONE

Active ingredients

PIRFENIDONE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ACCORD HLTHCARE

Manufacturer

Accord Healthcare Inc.

First approval

2022-01-25

Source

Authoritative

Drugs@FDA application overview

Machine

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