Application 022535

Type: NDA
Sponsor: GENENTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESBRIET	PIRFENIDONE	CAPSULE;ORAL	267MG	Yes	Yes

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
N022535-001	ESBRIET	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022535-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 19 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022535-001	7767225	2026-09-22	U-1602	Drug product	2014-11-14
N022535-001	7988994	2026-09-22	U-1602	Drug product	2014-11-14
N022535-001	8753679	2026-09-22	U-1602	Drug product	2014-11-14
N022535-001	7696236	2027-12-18	U-1601		2014-11-14
N022535-001	7767700	2027-12-18	U-1601		2014-11-14
N022535-001	8420674	2027-12-18	U-1608	Drug product	2014-11-14
N022535-001	8383150	2028-05-10	U-2361	Drug product	2014-11-14
N022535-001	7566729	2029-04-22	U-1600		2014-11-14
N022535-001	7635707	2029-04-22	U-1609		2014-11-14
N022535-001	8592462	2029-04-22	U-1609		2014-11-14
N022535-001	8609701	2029-04-22	U-1610		2014-11-14
N022535-001	7816383	2030-01-08	U-1603		2014-11-14
N022535-001	7910610	2030-01-08	U-1604		2014-11-14
N022535-001	8013002	2030-01-08	U-1603		2014-11-14
N022535-001	8084475	2030-01-08	U-1605		2014-11-14
N022535-001	8318780	2030-01-08	U-1606		2014-11-14
N022535-001	8648098	2030-01-08	U-1611		2014-11-14
N022535-001	8754109	2030-01-08	U-1612		2014-11-14
N022535-001	8778947	2033-08-30	U-1613		2014-11-14

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`cb3db0bc1861…`

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	N022535-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022535-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022535-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022535-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022535-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022535-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022535-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022535-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022535-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022535-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022535-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022535-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022535-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022535-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022535-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022535-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022535-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022535-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022535-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022535-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022535-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022535-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022535-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022535-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022535-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022535-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022535-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022535-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022535-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022535-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022535-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 782 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022535-001	7767225	2026-09-22	U-1602	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7988994	2026-09-22	U-1602	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8753679	2026-09-22	U-1602	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7696236	2027-12-18	U-1601		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7767700	2027-12-18	U-1601		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8420674	2027-12-18	U-1608	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8383150	2028-05-10	U-2361	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7566729	2029-04-22	U-1600		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7635707	2029-04-22	U-1609		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8592462	2029-04-22	U-1609		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8609701	2029-04-22	U-1610		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7816383	2030-01-08	U-1603		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7910610	2030-01-08	U-1604		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8013002	2030-01-08	U-1603		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8084475	2030-01-08	U-1605		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8318780	2030-01-08	U-1606		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8648098	2030-01-08	U-1611		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8754109	2030-01-08	U-1612		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8778947	2033-08-30	U-1613		2014-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7767225	2026-09-22	U-1602	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7988994	2026-09-22	U-1602	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8753679	2026-09-22	U-1602	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7696236	2027-12-18	U-1601		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7767700	2027-12-18	U-1601		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8420674	2027-12-18	U-1608	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8383150	2028-05-10	U-2361	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7566729	2029-04-22	U-1600		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7635707	2029-04-22	U-1609		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8592462	2029-04-22	U-1609		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8609701	2029-04-22	U-1610		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7816383	2030-01-08	U-1603		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7910610	2030-01-08	U-1604		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8013002	2030-01-08	U-1603		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8084475	2030-01-08	U-1605		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8318780	2030-01-08	U-1606		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8648098	2030-01-08	U-1611		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8754109	2030-01-08	U-1612		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8778947	2033-08-30	U-1613		2014-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022535-001	7767225	2026-09-22	U-1602	Drug product	2014-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022535-001	7988994	2026-09-22	U-1602	Drug product	2014-11-14	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022535-001	NCE	2019-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022535-001	ODE-77	2021-10-15	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022535-001	ODE-77	2021-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022535-001	ODE-77	2021-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022535-001	ODE-77	2021-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022535-001	ODE-77	2021-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022535-001	ODE-77	2021-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022535-001	NCE	2019-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022535-001	ODE-77	2021-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022535-001	NCE	2019-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022535-001	ODE-77	2021-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022535-001	NCE	2019-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022535-001	ODE-77	2021-10-15	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESBRIET	PIRFENIDONE	Genentech, Inc.	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	2025-12-05	Warnings, Adverse reactions	Exact identifier ndc (product): 50242-121

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-121	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-121	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-121	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-121	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-121	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-121	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-121	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-121	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
64116-121	Esbriet	pirfenidone	InterMune, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73647	SUPPL	2023-03-01
73611	SUPPL	2023-02-27
70163	SUPPL	2022-02-15
70153	SUPPL	2022-02-14
59560	SUPPL	2019-08-02
59537	SUPPL	2019-08-01
46875	SUPPL	2017-01-18
46801	SUPPL	2017-01-11
38824	SUPPL	2015-10-07
44773	ORIG	2014-12-05
42554	ORIG	2014-12-05
7513	ORIG	2014-10-22
17690	ORIG	2014-10-16