Orange Book product · Generic (ANDA)
PIRFENIDONE
PIRFENIDONE
At a glance
May 31, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 2023
3 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PIRFENIDONE
Strength
267MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 212709
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PIRFENIDONE
- 2017ESBRIETBrand (NDA)
NDA 208780 · LEGACY PHARMA
- 2014ESBRIETBrand (NDA)
NDA 022535 · LEGACY PHARMA
- 2026PIRFENIDONEGeneric (ANDA)
ANDA 212597 · AUROBINDO PHARMA
- 2025PIRFENIDONEGeneric (ANDA)
ANDA 212596 · AUROBINDO PHARMA
- 2024PIRFENIDONEGeneric (ANDA)
ANDA 212748 · MACLEODS PHARMS LTD
- 2023PIRFENIDONEGeneric (ANDA)
ANDA 212404 · CHARTWELL RX
- 2023PIRFENIDONEGeneric (ANDA)
ANDA 212403 · CHARTWELL RX
- 2023PIRFENIDONEGeneric (ANDA)
ANDA 212687 · APOTEX
- 2022PIRFENIDONEGeneric (ANDA)
ANDA 212674 · HETERO LABS LTD V
- 2022PIRFENIDONEGeneric (ANDA)
ANDA 212077 · SCIEGEN PHARMS
- 2022PIRFENIDONEGeneric (ANDA)
ANDA 212078 · SCIEGEN PHARMS
- 2022PIRFENIDONEGeneric (ANDA)
ANDA 212747 · AIZANT
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.
