FDA.reportPublic FDA data

Application 212403

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIRFENIDONEPIRFENIDONETABLET;ORAL267MGNoNo
002PIRFENIDONEPIRFENIDONETABLET;ORAL801MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212403-001PIRFENIDONEPIRFENIDONE267MGTABLET / ORAL2023-08-23
A212403-002PIRFENIDONEPIRFENIDONE801MGTABLET / ORAL2023-08-23

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
2026-08-01 22:54:322026-06A212403-001PIRFENIDONE267MGTABLET / ORAL2023-08-23a50c72e98297…
2026-08-01 22:54:322026-06A212403-002PIRFENIDONE801MGTABLET / ORAL2023-08-23a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PirfenidonePIRFENIDONEAurobindo Pharma Limited3115f15f-171c-4266-8dc8-5655f56e6acc2026-04-22Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAvKARE07ff87b3-0a88-15b4-e063-6294a90a72ab2026-01-14Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAvKARE08046b49-a8b3-a78d-e063-6394a90a80fa2026-01-14Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONEAccord Healthcare Inc.fab59395-1c5d-4c64-ba47-34d75736e9832025-12-17Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
ESBRIETPIRFENIDONEGenentech, Inc.2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e2025-12-05Warnings, Adverse reactionsName fallback
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEGolden State Medical Supply, Inc.1b3261fe-c066-6e86-e063-6294a90a675c2025-11-24Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEBryant Ranch Prepack33f1ca21-4c08-4103-889d-1d9c929b5fad2025-10-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEBryant Ranch Prepackbd3483bf-96e9-4d6b-a844-63bd002c48a42025-10-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEApotex Corp.9ccfe91e-d1fc-d4c1-115b-dd7859b2c3e62025-09-22Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEANI Pharmaceuticals, Inc.976620bb-c10e-4b13-8a97-7025fda6b7d52025-09-17Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAurobindo Pharma Limited50958060-c904-4374-997d-59df54007fa42025-08-13Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEBryant Ranch Prepackbfcb3157-cfa1-493d-9598-1e7fd3d355d92025-08-07Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEBryant Ranch Prepack9bdc7ed9-e51c-4101-a792-31619f05136b2025-08-07Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONELaurus Labs Limited29b0fd0e-5a2b-4da7-8524-177dc28bf55e2025-07-22Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
ESBRIETPIRFENIDONELegacy Pharma USA Inc.81f17f7d-cb04-4052-8682-dd3e330210ab2025-06-09Warnings, Adverse reactionsName fallback
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEMicro Labs Limited1abc06c7-6a45-4a0b-b2da-c228aaa137ed2025-06-04Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAmneal Pharmaceuticals NY LLC94362a07-7c64-42ce-adef-f49585af55d62025-05-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAmneal Pharmaceuticals NY LLC1d4d7aa2-1248-4639-baf5-5e2ae72cbcd82025-02-28Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAmneal Pharmaceuticals NY LLCea26490e-fd32-4807-8556-eb6f5f963c232024-11-04Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONESandoz Inc945d4337-7d18-4d84-807b-8ae13750c76d2024-10-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE