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

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N201292-001	GILOTRIF	EQ 20MG BASE	TABLET / ORAL	RLD	2013-07-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	GILOTRIF	EQ 30MG BASE	TABLET / ORAL	RLD	2013-07-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	GILOTRIF	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2013-07-12	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N201292-001	RE43431	2026-01-13		Drug substance	2013-08-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	RE43431*PED	2026-07-13		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	9539258	2026-11-09	U-1950		2017-02-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	9539258*PED	2027-05-09		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	8426586	2029-10-10		Drug substance	2013-08-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	8545884	2029-12-19		Drug product	2013-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	8426586*PED	2030-04-10		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	8545884*PED	2030-06-19		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	10004743	2030-07-05		Drug product	2018-08-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-001	10004743*PED	2031-01-05		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	RE43431	2026-01-13		Drug substance	2013-08-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	RE43431*PED	2026-07-13		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	9539258	2026-11-09	U-1950		2017-02-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	9539258*PED	2027-05-09		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	8426586	2029-10-10		Drug substance	2013-08-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	8545884	2029-12-19		Drug product	2013-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	8426586*PED	2030-04-10		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	8545884*PED	2030-06-19		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	10004743	2030-07-05		Drug product	2018-08-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-002	10004743*PED	2031-01-05		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	RE43431	2026-01-13		Drug substance	2013-08-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	RE43431*PED	2026-07-13		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	9539258	2026-11-09	U-1950		2017-02-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	9539258*PED	2027-05-09		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	8426586	2029-10-10		Drug substance	2013-08-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	8545884	2029-12-19		Drug product	2013-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	8426586*PED	2030-04-10		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	8545884*PED	2030-06-19		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	10004743	2030-07-05		Drug product	2018-08-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N201292-003	10004743*PED	2031-01-05		Pediatric extension		`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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