Application 212708

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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 1.

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
A212708-001	PIRFENIDONE	PIRFENIDONE	267MG	TABLET / ORAL	AB		2022-05-20
A212708-002	PIRFENIDONE	PIRFENIDONE	801MG	TABLET / ORAL	AB		2022-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212708-001	AB
A212708-002	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 2 · 58 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	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A212708-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212708-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212708-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212708-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212708-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212708-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212708-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212708-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212708-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212708-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212708-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212708-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212708-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212708-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212708-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212708-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212708-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212708-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212708-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212708-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212708-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212708-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212708-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212708-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212708-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212708-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212708-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212708-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212708-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212708-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212708-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212708-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212708-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212708-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212708-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212708-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212708-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212708-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212708-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212708-002	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 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	33f1ca21-4c08-4103-889d-1d9c929b5fad	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	bd3483bf-96e9-4d6b-a844-63bd002c48a4	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	bfcb3157-cfa1-493d-9598-1e7fd3d355d9	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	9bdc7ed9-e51c-4101-a792-31619f05136b	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Alembic Pharmaceuticals Inc.	9214862e-9ef7-4370-856a-f5697978270a	2023-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708 ndc (product): 62332-479 ndc (product): 62332-480
Pirfenidone	PIRFENIDONE	Alembic Pharmaceuticals Limited	6e4f991a-c9e3-4121-97d0-d07954f17336	2023-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Cipla USA Inc.	1927bf5d-1ef3-4a36-8dac-dc0a45b72fec	2022-08-26	Warnings, Adverse reactions	Exact identifier ndc (product): 69097-988
Pirfenidone	PIRFENIDONE	EXELAN PHARMACEUTICALS INC.	c171e4af-1619-4712-958f-ef96adfede37	2022-08-08	Warnings, Adverse reactions	Exact identifier ndc (product): 76282-717

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62332-479	Pirfenidone	Pirfenidone	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-480	Pirfenidone	Pirfenidone	Alembic Pharmaceuticals Inc.	ANDA	Current
69097-988	Pirfenidone	Pirfenidone	Cipla USA Inc.	ANDA	Current
69097-988	Pirfenidone	Pirfenidone	Cipla USA Inc.	ANDA	Current
76282-717	Pirfenidone	Pirfenidone	EXELAN PHARMACEUTICALS INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69655	ORIG	2021-12-20