Application 212404

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIRFENIDONE	PIRFENIDONE	CAPSULE;ORAL	267MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212404-001	PIRFENIDONE	PIRFENIDONE	267MG	CAPSULE / ORAL			2023-08-28

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2023-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2023-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2023-08-28	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212404-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2023-08-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A212404-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212404-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212404-001	AB	1	`9b2671bbb829…`

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 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pirfenidone	PIRFENIDONE	Aurobindo Pharma Limited	3115f15f-171c-4266-8dc8-5655f56e6acc	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	AvKARE	07ff87b3-0a88-15b4-e063-6294a90a72ab	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	AvKARE	08046b49-a8b3-a78d-e063-6394a90a80fa	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
PIRFENIDONE	PIRFENIDONE	Accord Healthcare Inc.	fab59395-1c5d-4c64-ba47-34d75736e983	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: PIRFENIDONE generic name: PIRFENIDONE
ESBRIET	PIRFENIDONE	Genentech, Inc.	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Golden State Medical Supply, Inc.	1b3261fe-c066-6e86-e063-6294a90a675c	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	33f1ca21-4c08-4103-889d-1d9c929b5fad	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	bd3483bf-96e9-4d6b-a844-63bd002c48a4	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Apotex Corp.	9ccfe91e-d1fc-d4c1-115b-dd7859b2c3e6	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	ANI Pharmaceuticals, Inc.	976620bb-c10e-4b13-8a97-7025fda6b7d5	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Aurobindo Pharma Limited	50958060-c904-4374-997d-59df54007fa4	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	bfcb3157-cfa1-493d-9598-1e7fd3d355d9	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	9bdc7ed9-e51c-4101-a792-31619f05136b	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Laurus Labs Limited	29b0fd0e-5a2b-4da7-8524-177dc28bf55e	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
ESBRIET	PIRFENIDONE	Legacy Pharma USA Inc.	81f17f7d-cb04-4052-8682-dd3e330210ab	2025-06-09	Warnings, Adverse reactions	Name fallback generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Micro Labs Limited	1abc06c7-6a45-4a0b-b2da-c228aaa137ed	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Amneal Pharmaceuticals NY LLC	94362a07-7c64-42ce-adef-f49585af55d6	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Amneal Pharmaceuticals NY LLC	1d4d7aa2-1248-4639-baf5-5e2ae72cbcd8	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Amneal Pharmaceuticals NY LLC	ea26490e-fd32-4807-8556-eb6f5f963c23	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Sandoz Inc	945d4337-7d18-4d84-807b-8ae13750c76d	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE