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PIRFENIDONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2024-12-18

Drug application

FDA Application #

ANDA212748

Application type

Abbreviated New Drug Application (Generic)

Brand name

PIRFENIDONE

Generic name

PIRFENIDONE CAPSULE, 267 MG

Active ingredients

PIRFENIDONE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

MACLEODS PHARMS LTD

Manufacturer

Macleods Pharmaceuticals Limited

First approval

2024-12-18

Source

Authoritative

Drugs@FDA application overview

Machine

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