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PIRFENIDONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2026-04-20

Drug application

FDA Application #
ANDA212597
Application type
Abbreviated New Drug Application (Generic)
Brand name
PIRFENIDONE
Generic name
PIRFENIDONE
Active ingredients
PIRFENIDONE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
AUROBINDO PHARMA
Manufacturer
Aurobindo Pharma Limited
First approval
2026-04-20

Source

Authoritative
Drugs@FDA application overview
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