Application 205832

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OFEV	NINTEDANIB ESYLATE	CAPSULE;ORAL	EQ 100MG BASE	Yes	No
002	OFEV	NINTEDANIB ESYLATE	CAPSULE;ORAL	EQ 150MG BASE	Yes	Yes

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
N205832-001	OFEV	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2014-10-15
N205832-002	OFEV	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N205832-001	AB
N205832-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205832-001	6762180	2025-10-01		Drug substance, Drug product	2014-10-22
N205832-001	10154990	2026-01-08	U-2620		2019-09-18
N205832-001	6762180*PED	2026-04-01		Pediatric extension
N205832-001	10154990*PED	2026-07-08		Pediatric extension
N205832-001	10105323	2029-06-04		Drug product	2018-11-06
N205832-001	9907756	2029-06-07		Drug product	2018-04-04
N205832-001	10105323*PED	2029-12-04		Pediatric extension
N205832-001	9907756*PED	2029-12-07		Pediatric extension
N205832-002	6762180	2025-10-01		Drug substance, Drug product	2014-10-22
N205832-002	10154990	2026-01-08	U-2620		2019-09-18
N205832-002	6762180*PED	2026-04-01		Pediatric extension
N205832-002	10154990*PED	2026-07-08		Pediatric extension
N205832-002	10105323	2029-06-04		Drug product	2018-11-06
N205832-002	9907756	2029-06-07		Drug product	2018-04-04
N205832-002	10105323*PED	2029-12-04		Pediatric extension
N205832-002	9907756*PED	2029-12-07		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205832-001	ODE-261	2026-09-06
N205832-001	PED	2027-03-06
N205832-002	ODE-261	2026-09-06
N205832-002	PED	2027-03-06

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 · 86 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
2026-09-14 22:38:34	2026-08	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2014-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2014-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL		RLD	2014-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N205832-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205832-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205832-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205832-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 586 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205832-001	6762180	2025-10-01		Drug substance, Drug product	2014-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-001	10154990	2026-01-08	U-2620		2019-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-001	6762180*PED	2026-04-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-001	10154990*PED	2026-07-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-001	10105323	2029-06-04		Drug product	2018-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-001	9907756	2029-06-07		Drug product	2018-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-001	10105323*PED	2029-12-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-001	9907756*PED	2029-12-07		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	6762180	2025-10-01		Drug substance, Drug product	2014-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	10154990	2026-01-08	U-2620		2019-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	6762180*PED	2026-04-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	10154990*PED	2026-07-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	10105323	2029-06-04		Drug product	2018-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	9907756	2029-06-07		Drug product	2018-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	10105323*PED	2029-12-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	9907756*PED	2029-12-07		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205832-001	6762180	2025-10-01		Drug substance, Drug product	2014-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-001	10154990	2026-01-08	U-2620		2019-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-001	6762180*PED	2026-04-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-001	10154990*PED	2026-07-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-001	10105323	2029-06-04		Drug product	2018-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-001	9907756	2029-06-07		Drug product	2018-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-001	10105323*PED	2029-12-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-001	9907756*PED	2029-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	6762180	2025-10-01		Drug substance, Drug product	2014-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	10154990	2026-01-08	U-2620		2019-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	6762180*PED	2026-04-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	10154990*PED	2026-07-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	10105323	2029-06-04		Drug product	2018-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	9907756	2029-06-07		Drug product	2018-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	10105323*PED	2029-12-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	9907756*PED	2029-12-07		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205832-001	6762180	2025-10-01		Drug substance, Drug product	2014-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-001	10154990	2026-01-08	U-2620		2019-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-001	6762180*PED	2026-04-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-001	10154990*PED	2026-07-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-001	10105323	2029-06-04		Drug product	2018-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-001	9907756	2029-06-07		Drug product	2018-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-001	10105323*PED	2029-12-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-001	9907756*PED	2029-12-07		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 222 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N205832-001	ODE-261	2026-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-001	PED	2027-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	ODE-261	2026-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205832-002	PED	2027-03-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205832-001	ODE-261	2026-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-001	PED	2027-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	ODE-261	2026-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205832-002	PED	2027-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205832-001	ODE-261	2026-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-001	PED	2027-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-002	ODE-261	2026-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205832-002	PED	2027-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205832-001	ODE-261	2026-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205832-001	PED	2027-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205832-002	ODE-261	2026-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205832-002	PED	2027-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205832-001	ODE-261	2026-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205832-001	PED	2027-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205832-002	ODE-261	2026-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205832-002	PED	2027-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205832-001	ODE-261	2026-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205832-001	PED	2027-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205832-002	ODE-261	2026-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205832-002	PED	2027-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205832-001	ODE-261	2026-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205832-001	PED	2027-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205832-002	ODE-261	2026-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205832-002	PED	2027-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205832-001	ODE-261	2026-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205832-001	PED	2027-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205832-002	ODE-261	2026-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205832-002	PED	2027-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205832-001	ODE-261	2026-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205832-001	PED	2027-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205832-002	ODE-261	2026-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205832-002	PED	2027-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205832-001	ODE-261	2026-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205832-001	PED	2027-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205832-002	ODE-261	2026-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205832-002	PED	2027-03-06	`5bbf6a4d5a75…`

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
Ofev	NINTEDANIB	Boehringer Ingelheim Pharmaceuticals, Inc.	da1c9f37-779e-4682-816f-93d0faa4cfc9	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205832 application number: NDA205832 ndc (product): 0597-0143 ndc (product): 0597-0145

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0143	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0143	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0143	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0143	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0143	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0143	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0145	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0145	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0145	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0145	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0145	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0145	Ofev	nintedanib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79904	SUPPL	2024-10-15
79879	SUPPL	2024-10-14
78855	SUPPL	2024-06-20
78849	SUPPL	2024-06-20
71489	SUPPL	2022-06-30
69916	SUPPL	2022-01-19
69892	SUPPL	2022-01-18
65117	SUPPL	2020-11-02
65080	SUPPL	2020-10-30
62188	SUPPL	2020-03-18
62101	SUPPL	2020-03-10
62095	SUPPL	2020-03-09
59951	SUPPL	2019-09-10
59942	SUPPL	2019-09-09
56471	SUPPL	2018-11-15
56415	SUPPL	2018-11-12
52272	SUPPL	2018-02-02
52081	SUPPL	2018-01-30
50753	SUPPL	2017-12-18
50679	SUPPL	2017-12-13
49362	SUPPL	2017-08-15
49276	SUPPL	2017-08-08
47176	SUPPL	2017-02-13
47168	SUPPL	2017-02-10
19688	SUPPL	2016-03-04
10508	SUPPL	2016-02-05
24507	ORIG	2014-12-17
23005	ORIG	2014-11-21
10507	ORIG	2014-10-21
19687	ORIG	2014-10-16