Application 201292

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GILOTRIF	AFATINIB DIMALEATE	TABLET;ORAL	EQ 20MG BASE	Yes	No
002	GILOTRIF	AFATINIB DIMALEATE	TABLET;ORAL	EQ 30MG BASE	Yes	No
003	GILOTRIF	AFATINIB DIMALEATE	TABLET;ORAL	EQ 40MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N201292-001	GILOTRIF	AFATINIB DIMALEATE	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2013-07-12
N201292-002	GILOTRIF	AFATINIB DIMALEATE	EQ 30MG BASE	TABLET / ORAL	AB	RLD	2013-07-12
N201292-003	GILOTRIF	AFATINIB DIMALEATE	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2013-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N201292-001	AB
N201292-002	AB
N201292-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201292-001	RE43431	2026-01-13		Drug substance	2013-08-01
N201292-001	RE43431*PED	2026-07-13		Pediatric extension
N201292-001	9539258	2026-11-09	U-1950		2017-02-02
N201292-001	9539258*PED	2027-05-09		Pediatric extension
N201292-001	8426586	2029-10-10		Drug substance	2013-08-01
N201292-001	8545884	2029-12-19		Drug product	2013-10-28
N201292-001	8426586*PED	2030-04-10		Pediatric extension
N201292-001	8545884*PED	2030-06-19		Pediatric extension
N201292-001	10004743	2030-07-05		Drug product	2018-08-02
N201292-001	10004743*PED	2031-01-05		Pediatric extension
N201292-002	RE43431	2026-01-13		Drug substance	2013-08-01
N201292-002	RE43431*PED	2026-07-13		Pediatric extension
N201292-002	9539258	2026-11-09	U-1950		2017-02-02
N201292-002	9539258*PED	2027-05-09		Pediatric extension
N201292-002	8426586	2029-10-10		Drug substance	2013-08-01
N201292-002	8545884	2029-12-19		Drug product	2013-10-28
N201292-002	8426586*PED	2030-04-10		Pediatric extension
N201292-002	8545884*PED	2030-06-19		Pediatric extension
N201292-002	10004743	2030-07-05		Drug product	2018-08-02
N201292-002	10004743*PED	2031-01-05		Pediatric extension
N201292-003	RE43431	2026-01-13		Drug substance	2013-08-01
N201292-003	RE43431*PED	2026-07-13		Pediatric extension
N201292-003	9539258	2026-11-09	U-1950		2017-02-02
N201292-003	9539258*PED	2027-05-09		Pediatric extension
N201292-003	8426586	2029-10-10		Drug substance	2013-08-01
N201292-003	8545884	2029-12-19		Drug product	2013-10-28
N201292-003	8426586*PED	2030-04-10		Pediatric extension
N201292-003	8545884*PED	2030-06-19		Pediatric extension
N201292-003	10004743	2030-07-05		Drug product	2018-08-02
N201292-003	10004743*PED	2031-01-05		Pediatric extension

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N201292-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201292-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201292-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201292-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201292-003	AB	1	`caaa826d4ba7…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,170 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N201292-001	RE43431	2026-01-13		Drug substance	2013-08-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	RE43431*PED	2026-07-13		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	9539258	2026-11-09	U-1950		2017-02-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	9539258*PED	2027-05-09		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	8426586	2029-10-10		Drug substance	2013-08-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	8545884	2029-12-19		Drug product	2013-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	8426586*PED	2030-04-10		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	8545884*PED	2030-06-19		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	10004743	2030-07-05		Drug product	2018-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-001	10004743*PED	2031-01-05		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	RE43431	2026-01-13		Drug substance	2013-08-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	RE43431*PED	2026-07-13		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	9539258	2026-11-09	U-1950		2017-02-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	9539258*PED	2027-05-09		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	8426586	2029-10-10		Drug substance	2013-08-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	8545884	2029-12-19		Drug product	2013-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	8426586*PED	2030-04-10		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	8545884*PED	2030-06-19		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	10004743	2030-07-05		Drug product	2018-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-002	10004743*PED	2031-01-05		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	RE43431	2026-01-13		Drug substance	2013-08-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	RE43431*PED	2026-07-13		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	9539258	2026-11-09	U-1950		2017-02-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	9539258*PED	2027-05-09		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	8426586	2029-10-10		Drug substance	2013-08-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	8545884	2029-12-19		Drug product	2013-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	8426586*PED	2030-04-10		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	8545884*PED	2030-06-19		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	10004743	2030-07-05		Drug product	2018-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N201292-003	10004743*PED	2031-01-05		Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N201292-001	RE43431	2026-01-13		Drug substance	2013-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	RE43431*PED	2026-07-13		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	9539258	2026-11-09	U-1950		2017-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	9539258*PED	2027-05-09		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	8426586	2029-10-10		Drug substance	2013-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	8545884	2029-12-19		Drug product	2013-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	8426586*PED	2030-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	8545884*PED	2030-06-19		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	10004743	2030-07-05		Drug product	2018-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201292-001	10004743*PED	2031-01-05		Pediatric extension		`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 14 · 523 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-001	ODE-230	2025-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-001	M-276	2025-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-001	PED	2025-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-001	PED	2025-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-002	ODE-230	2025-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-002	M-276	2025-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-002	PED	2025-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-002	PED	2025-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-003	ODE-230	2025-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-003	M-276	2025-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-003	PED	2025-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201292-003	PED	2025-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201292-001	ODE-230	2025-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-001	M-276	2025-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-001	PED	2025-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-001	PED	2025-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-002	ODE-230	2025-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-002	M-276	2025-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-002	PED	2025-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-002	PED	2025-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-003	ODE-230	2025-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-003	M-276	2025-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-003	PED	2025-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201292-003	PED	2025-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-001	ODE-230	2025-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-001	M-276	2025-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-001	PED	2025-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-001	PED	2025-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-002	ODE-230	2025-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-002	M-276	2025-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-002	PED	2025-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-002	PED	2025-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-003	ODE-230	2025-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-003	M-276	2025-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-003	PED	2025-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201292-003	PED	2025-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201292-001	ODE-230	2025-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201292-001	M-276	2025-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201292-001	PED	2025-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201292-001	PED	2025-10-07	`b8a1b40f171c…`

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
Gilotrif	AFATINIB	Boehringer Ingelheim Pharmaceuticals, Inc.	fd638e5e-8032-e7ca-0179-95e96ab5d387	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201292 application number: NDA201292 ndc (product): 0597-0141 ndc (product): 0597-0138 ndc (product): 0597-0137

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0597-0137	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0137	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0137	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0137	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0138	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0138	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0138	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0138	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0141	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0141	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0141	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0141	Gilotrif	afatinib	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70746	SUPPL	2022-04-11
70734	SUPPL	2022-04-08
60551	SUPPL	2019-10-15
60550	SUPPL	2019-10-15
51064	SUPPL	2018-01-17
51049	SUPPL	2018-01-12
50353	SUPPL	2017-11-09
50323	SUPPL	2017-11-07
45506	SUPPL	2016-10-06
45498	SUPPL	2016-10-06
19013	SUPPL	2016-04-27
9885	SUPPL	2016-04-22
19011	SUPPL	2016-04-19
32104	SUPPL	2016-04-18
19012	SUPPL	2015-12-31
9884	SUPPL	2015-12-29
9883	SUPPL	2015-11-13
19010	SUPPL	2015-11-12
32103	SUPPL	2013-11-25
40065	SUPPL	2013-11-22
43364	SUPPL	2013-10-23
44834	ORIG	2013-08-15
43363	ORIG	2013-08-15
40064	SUPPL	2013-07-30
32102	SUPPL	2013-07-26
19009	ORIG	2013-07-12
9882	ORIG	2013-07-12