FDA.reportPublic FDA data

Application 212687

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIRFENIDONEPIRFENIDONECAPSULE;ORAL267MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212687-001PIRFENIDONEPIRFENIDONE267MGCAPSULE / ORAL2023-06-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-0984e616aacf4f…
2026-08-18 06:07:402026-07A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212687-001PIRFENIDONE267MGCAPSULE / ORALAB2023-06-09a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212687-001PIRFENIDONE267MGCAPSULE / ORAL2023-06-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212687-001AB1a67488948f0b…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIRFENIDONEPIRFENIDONENovadoz Pharmaceuticals LLC741d1b9c-e281-4eca-b327-e25e823130062024-07-23Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONENorthstar Rx LLC5d0eee8c-dc7d-4444-8684-e9c9335291c82024-03-08Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAlembic Pharmaceuticals Inc.9214862e-9ef7-4370-856a-f5697978270a2023-12-06Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONEScieGen Pharmaceuticals, Inc.1fbdb556-b164-4e0b-a95e-6004d50e33642023-11-09Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONEScieGen Pharmaceuticals, Inc.155b948e-47f5-4741-8e82-2ed65ccfab7d2023-11-08Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PirfenidonePIRFENIDONECamber Pharmaceuticals, Inc.a7f3485e-9dcc-45db-9b9c-74c70e22c4bb2023-05-11Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONESandoz Inc7f5f7cc9-394e-4da0-87eb-84cfff9707a32023-04-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAmneal Pharmaceuticals NY LLCa235768d-d26d-4ded-ae75-53e93310ff6a2023-04-10Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAlembic Pharmaceuticals Limited6e4f991a-c9e3-4121-97d0-d07954f173362023-03-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONEEXELAN PHARMACEUTICALS INC.1709582c-9975-4dc1-8181-2501ee670eef2023-01-20Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PirfenidonePIRFENIDONECipla USA Inc.1927bf5d-1ef3-4a36-8dac-dc0a45b72fec2022-08-26Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEEXELAN PHARMACEUTICALS INC.c171e4af-1619-4712-958f-ef96adfede372022-08-08Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONECipla USA Inc.16fca4fc-b641-4ee8-a2ee-a35189ce1f3b2022-08-03Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61123ORIG2019-12-03