Application 212569

Type: ANDA
Sponsor: AMNEAL

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
A212569-001	PIRFENIDONE	PIRFENIDONE	267MG	CAPSULE / ORAL	AB		2022-01-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212569-001	AB

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	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2022-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2022-01-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL		2022-01-03	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212569-001	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	2022-01-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212569-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212569-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212569-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212569-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212569-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212569-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212569-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212569-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212569-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212569-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212569-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212569-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212569-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212569-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212569-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212569-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212569-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212569-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212569-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212569-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212569-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212569-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212569-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212569-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212569-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212569-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212569-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212569-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212569-001	AB	1	`a50c72e98297…`

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pirfenidone	PIRFENIDONE	AvKARE	07ff87b3-0a88-15b4-e063-6294a90a72ab	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212569 application number: ANDA212569
Pirfenidone	PIRFENIDONE	Amneal Pharmaceuticals NY LLC	1d4d7aa2-1248-4639-baf5-5e2ae72cbcd8	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212569 application number: ANDA212569 ndc (product): 60219-1642
Pirfenidone	PIRFENIDONE	Amneal Pharmaceuticals NY LLC	ea26490e-fd32-4807-8556-eb6f5f963c23	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212569 application number: ANDA212569

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60219-1642	Pirfenidone	Pirfenidone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1642	Pirfenidone	Pirfenidone	Amneal Pharmaceuticals NY LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63033	ORIG	2020-05-15