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 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
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.

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
2026-08-01 22:54:32	2026-06	N205832-001	OFEV	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2014-10-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	OFEV	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N205832-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	AB	1	`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	N205832-001	6762180	2025-10-01		Drug substance, Drug product	2014-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-001	10154990	2026-01-08	U-2620		2019-09-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-001	6762180*PED	2026-04-01		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-001	10154990*PED	2026-07-08		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-001	10105323	2029-06-04		Drug product	2018-11-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-001	9907756	2029-06-07		Drug product	2018-04-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-001	10105323*PED	2029-12-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-001	9907756*PED	2029-12-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	6762180	2025-10-01		Drug substance, Drug product	2014-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	10154990	2026-01-08	U-2620		2019-09-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	6762180*PED	2026-04-01		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	10154990*PED	2026-07-08		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	10105323	2029-06-04		Drug product	2018-11-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	9907756	2029-06-07		Drug product	2018-04-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	10105323*PED	2029-12-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	9907756*PED	2029-12-07		Pediatric extension		`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N205832-001	ODE-261	2026-09-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-001	PED	2027-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	ODE-261	2026-09-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205832-002	PED	2027-03-06	`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
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