APPLICATION
ANDA212596
TYPE
ANDA
ORIGINAL APPROVAL
2025-08-11
LATEST ACTION
2025-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PIRFENIDONEPrescription
PIRFENIDONE 801MG · TABLET · ORAL
PIRFENIDONEPrescription
PIRFENIDONE 267MG · TABLET · ORAL
Approval history
2025-08-11UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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