Application 212403

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIRFENIDONE	PIRFENIDONE	TABLET;ORAL	267MG	No	No
002	PIRFENIDONE	PIRFENIDONE	TABLET;ORAL	801MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212403-001	PIRFENIDONE	PIRFENIDONE	267MG	TABLET / ORAL			2023-08-23
A212403-002	PIRFENIDONE	PIRFENIDONE	801MG	TABLET / ORAL			2023-08-23

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.

Product history page 1 of 2 · 44 observed 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
2026-09-14 22:38:34	2026-08	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL		2023-08-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL		2023-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2023-08-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2023-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212403-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2023-08-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212403-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2023-08-23	`a72a2bbeb626…`

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	A212403-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212403-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212403-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212403-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212403-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212403-002	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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PIRFENIDONE	PIRFENIDONE	Novadoz Pharmaceuticals LLC	741d1b9c-e281-4eca-b327-e25e82313006	2024-07-23	Warnings, Adverse reactions	Name fallback brand name: PIRFENIDONE generic name: PIRFENIDONE
PIRFENIDONE	PIRFENIDONE	Northstar Rx LLC	5d0eee8c-dc7d-4444-8684-e9c9335291c8	2024-03-08	Warnings, Adverse reactions	Name fallback brand name: PIRFENIDONE generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Alembic Pharmaceuticals Inc.	9214862e-9ef7-4370-856a-f5697978270a	2023-12-06	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
PIRFENIDONE	PIRFENIDONE	ScieGen Pharmaceuticals, Inc.	1fbdb556-b164-4e0b-a95e-6004d50e3364	2023-11-09	Warnings, Adverse reactions	Name fallback brand name: PIRFENIDONE generic name: PIRFENIDONE
PIRFENIDONE	PIRFENIDONE	ScieGen Pharmaceuticals, Inc.	155b948e-47f5-4741-8e82-2ed65ccfab7d	2023-11-08	Warnings, Adverse reactions	Name fallback brand name: PIRFENIDONE generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Camber Pharmaceuticals, Inc.	a7f3485e-9dcc-45db-9b9c-74c70e22c4bb	2023-05-11	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Sandoz Inc	7f5f7cc9-394e-4da0-87eb-84cfff9707a3	2023-04-30	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Amneal Pharmaceuticals NY LLC	a235768d-d26d-4ded-ae75-53e93310ff6a	2023-04-10	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Alembic Pharmaceuticals Limited	6e4f991a-c9e3-4121-97d0-d07954f17336	2023-03-30	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
PIRFENIDONE	PIRFENIDONE	EXELAN PHARMACEUTICALS INC.	1709582c-9975-4dc1-8181-2501ee670eef	2023-01-20	Warnings, Adverse reactions	Name fallback brand name: PIRFENIDONE generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	Cipla USA Inc.	1927bf5d-1ef3-4a36-8dac-dc0a45b72fec	2022-08-26	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
Pirfenidone	PIRFENIDONE	EXELAN PHARMACEUTICALS INC.	c171e4af-1619-4712-958f-ef96adfede37	2022-08-08	Warnings, Adverse reactions	Name fallback brand name: Pirfenidone generic name: PIRFENIDONE
PIRFENIDONE	PIRFENIDONE	Cipla USA Inc.	16fca4fc-b641-4ee8-a2ee-a35189ce1f3b	2022-08-03	Warnings, Adverse reactions	Name fallback brand name: PIRFENIDONE generic name: PIRFENIDONE

Reported adverse events (FAERS/openFDA)#

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