Application 212722

Type: ANDA
Sponsor: PharmaQ, Inc.

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	534MG	No	No
003	PIRFENIDONE	PIRFENIDONE	TABLET;ORAL	801MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212722-001	PIRFENIDONE	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19
A212722-002	PIRFENIDONE	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19
A212722-003	PIRFENIDONE	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212722-001	AB
A212722-002	AB
A212722-003	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.

Product history page 1 of 3 · 81 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
2026-02-19 14:30 UTC	2026-02	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212722-002	PIRFENIDONE	534MG	TABLET / ORAL	AB	2022-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212722-003	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212722-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-07-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212722-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212722-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212722-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212722-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212722-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212722-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212722-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212722-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212722-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212722-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212722-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212722-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212722-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212722-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212722-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212722-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212722-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212722-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212722-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212722-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212722-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212722-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212722-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212722-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212722-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212722-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212722-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212722-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212722-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212722-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212722-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212722-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212722-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212722-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212722-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212722-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212722-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212722-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212722-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212722-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pirfenidone	PIRFENIDONE	ANI Pharmaceuticals, Inc.	976620bb-c10e-4b13-8a97-7025fda6b7d5	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212722 application number: ANDA212722
Pirfenidone	PIRFENIDONE	Laurus Labs Limited	29b0fd0e-5a2b-4da7-8524-177dc28bf55e	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212722 application number: ANDA212722 ndc (product): 42385-925 ndc (product): 42385-924 ndc (product): 42385-926

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42385-924	Pirfenidone	Pirfenidone	Laurus Labs Limited	ANDA	Current
42385-925	Pirfenidone	Pirfenidone	Laurus Labs Limited	ANDA	Current
42385-926	Pirfenidone	Pirfenidone	Laurus Labs Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64639	ORIG	2020-09-22