Application 022512

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 75MG BASE	Yes	No
002	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 150MG BASE	Yes	Yes
003	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 110MG BASE	Yes	No

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	TE codes	RLD / RS	Approval date
N022512-001	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19
N022512-002	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19
N022512-003	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022512-001	AB
N022512-002	AB
N022512-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022512-001	7932273	2025-09-07		Drug substance, Drug product	2011-08-01
N022512-001	7932273*PED	2026-03-07		Pediatric extension
N022512-001	9034822	2031-01-20	U-1759		2015-11-09
N022512-001	9034822*PED	2031-07-20		Pediatric extension
N022512-002	7932273	2025-09-07		Drug substance, Drug product
N022512-002	7932273*PED	2026-03-07		Pediatric extension
N022512-002	9034822	2031-01-20	U-1759		2015-11-09
N022512-002	9034822*PED	2031-07-20		Pediatric extension
N022512-003	7932273	2025-09-07		Drug substance, Drug product	2015-12-15
N022512-003	7932273*PED	2026-03-07		Pediatric extension
N022512-003	9034822	2031-01-20	U-1759		2015-12-15
N022512-003	9034822*PED	2031-07-20		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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`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	N022512-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-003	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	N022512-001	7932273	2025-09-07		Drug substance, Drug product	2011-08-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-001	7932273*PED	2026-03-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-001	9034822	2031-01-20	U-1759		2015-11-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-001	9034822*PED	2031-07-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-002	7932273	2025-09-07		Drug substance, Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-002	7932273*PED	2026-03-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-002	9034822	2031-01-20	U-1759		2015-11-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-002	9034822*PED	2031-07-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-003	7932273	2025-09-07		Drug substance, Drug product	2015-12-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-003	7932273*PED	2026-03-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-003	9034822	2031-01-20	U-1759		2015-12-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022512-003	9034822*PED	2031-07-20		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
Pradaxa	DABIGATRAN ETEXILATE MESYLATE	Boehringer Ingelheim Pharmaceuticals Inc.	ba74e3cd-b06f-4145-b284-5fd6b84ff3c9	2025-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022512 application number: NDA022512 ndc (product): 0597-0360 ndc (product): 0597-0355 ndc (product): 0597-0108

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0135	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0135	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0149	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
21695-899	PRADAXA	dabigatran etexilate mesylate	Rebel Distributors Corp	NDA	Current
50090-3617	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-3617	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-3617	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-3617	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
63629-8242	Pradaxa	dabigatran etexilate mesylate	Bryant Ranch Prepack	NDA	Current
63629-8242	Pradaxa	dabigatran etexilate mesylate	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83206	SUPPL	2025-10-03
82606	SUPPL	2025-10-03
83097	SUPPL	2025-08-13
82607	SUPPL	2025-06-20
76640	SUPPL	2024-01-12
76636	SUPPL	2023-11-20
67870	SUPPL	2021-06-23
67849	SUPPL	2021-06-22
67848	SUPPL	2021-06-22
67154	SUPPL	2021-04-22
67133	SUPPL	2021-04-22
63791	SUPPL	2020-07-06
63782	SUPPL	2020-07-02
63781	SUPPL	2020-07-02
61052	SUPPL	2019-11-26
61044	SUPPL	2019-11-25
61043	SUPPL	2019-11-25
52983	SUPPL	2018-03-15
52977	SUPPL	2018-03-15
38798	SUPPL	2015-11-25
7486	SUPPL	2015-11-23
38799	SUPPL	2015-10-27
7487	SUPPL	2015-10-26
17667	SUPPL	2015-09-21
7485	SUPPL	2015-09-14
38797	SUPPL	2015-09-11
29813	SUPPL	2015-08-28
38795	SUPPL	2015-01-20
7483	SUPPL	2015-01-20
38796	SUPPL	2014-09-26
7484	SUPPL	2014-09-08
38794	SUPPL	2014-08-15
7482	SUPPL	2014-08-15
29812	SUPPL	2014-04-09
38792	SUPPL	2014-04-08
7481	SUPPL	2013-12-13
38793	SUPPL	2013-12-11
22043	SUPPL	2013-06-04
29811	SUPPL	2013-04-30
38791	SUPPL	2013-04-29
42544	SUPPL	2013-04-10
23407	ORIG	2013-01-03
29810	SUPPL	2012-12-26
38790	SUPPL	2012-12-21
38789	SUPPL	2012-11-06
7480	SUPPL	2012-11-06
17666	SUPPL	2012-06-11
29809	SUPPL	2012-06-05
29808	SUPPL	2012-05-02
17665	SUPPL	2012-05-01
38788	SUPPL	2012-01-23
29807	SUPPL	2012-01-19
7479	SUPPL	2011-11-14
38787	SUPPL	2011-11-10
7478	SUPPL	2011-04-07
44186	ORIG	2011-03-29
29806	SUPPL	2011-03-08
38786	SUPPL	2011-03-07
24328	ORIG	2011-02-17
22042	ORIG	2010-11-30
29805	ORIG	2010-10-20
17664	ORIG	2010-10-20