Application 214358

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRADAXA	DABIGATRAN	PELLETS;ORAL	20MG	No	No
002	PRADAXA	DABIGATRAN	PELLETS;ORAL	30MG	No	No
003	PRADAXA	DABIGATRAN	PELLETS;ORAL	40MG	No	No
004	PRADAXA	DABIGATRAN	PELLETS;ORAL	50MG	No	No
005	PRADAXA	DABIGATRAN	PELLETS;ORAL	110MG	No	No
006	PRADAXA	DABIGATRAN	PELLETS;ORAL	150MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214358-001	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 20MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21
N214358-002	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 30MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21
N214358-003	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 40MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21
N214358-004	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 50MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21
N214358-005	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21
N214358-006	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE/PACKET	PELLETS / ORAL	RLD, RS	2021-06-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N214358-001	7932273	2025-09-07	Drug substance, Drug product	2021-07-28
N214358-001	7932273*PED	2026-03-07	Pediatric extension
N214358-002	7932273	2025-09-07	Drug substance, Drug product	2021-07-28
N214358-002	7932273*PED	2026-03-07	Pediatric extension
N214358-003	7932273	2025-09-07	Drug substance, Drug product	2021-07-28
N214358-003	7932273*PED	2026-03-07	Pediatric extension
N214358-004	7932273	2025-09-07	Drug substance, Drug product	2021-07-28
N214358-004	7932273*PED	2026-03-07	Pediatric extension
N214358-005	7932273	2025-09-07	Drug substance, Drug product	2021-07-28
N214358-005	7932273*PED	2026-03-07	Pediatric extension
N214358-006	7932273	2025-09-07	Drug substance, Drug product	2021-07-28
N214358-006	7932273*PED	2026-03-07	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 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214358-001	PRADAXA	EQ 20MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-002	PRADAXA	EQ 30MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-003	PRADAXA	EQ 40MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-004	PRADAXA	EQ 50MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-005	PRADAXA	EQ 110MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-006	PRADAXA	EQ 150MG BASE/PACKET	PELLETS / ORAL	RLD, RS	2021-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214358-001	PRADAXA	EQ 20MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-002	PRADAXA	EQ 30MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-003	PRADAXA	EQ 40MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-004	PRADAXA	EQ 50MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-005	PRADAXA	EQ 110MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-006	PRADAXA	EQ 150MG BASE/PACKET	PELLETS / ORAL	RLD, RS	2021-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-001	PRADAXA	EQ 20MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-002	PRADAXA	EQ 30MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-003	PRADAXA	EQ 40MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-004	PRADAXA	EQ 50MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-005	PRADAXA	EQ 110MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-006	PRADAXA	EQ 150MG BASE/PACKET	PELLETS / ORAL	RLD, RS	2021-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214358-001	PRADAXA	EQ 20MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214358-002	PRADAXA	EQ 30MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214358-003	PRADAXA	EQ 40MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214358-004	PRADAXA	EQ 50MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214358-005	PRADAXA	EQ 110MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214358-006	PRADAXA	EQ 150MG BASE/PACKET	PELLETS / ORAL	RLD, RS	2021-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214358-001	PRADAXA	EQ 20MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214358-002	PRADAXA	EQ 30MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214358-003	PRADAXA	EQ 40MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214358-004	PRADAXA	EQ 50MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214358-005	PRADAXA	EQ 110MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214358-006	PRADAXA	EQ 150MG BASE/PACKET	PELLETS / ORAL	RLD, RS	2021-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214358-001	PRADAXA	EQ 20MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214358-002	PRADAXA	EQ 30MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214358-003	PRADAXA	EQ 40MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214358-004	PRADAXA	EQ 50MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214358-005	PRADAXA	EQ 110MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214358-006	PRADAXA	EQ 150MG BASE/PACKET	PELLETS / ORAL	RLD, RS	2021-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-001	PRADAXA	EQ 20MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-002	PRADAXA	EQ 30MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-003	PRADAXA	EQ 40MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-004	PRADAXA	EQ 50MG BASE/PACKET	PELLETS / ORAL	RLD	2021-06-21	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 672 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214358-001	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-001	7932273*PED	2026-03-07	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-002	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-002	7932273*PED	2026-03-07	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-003	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-003	7932273*PED	2026-03-07	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-004	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-004	7932273*PED	2026-03-07	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-005	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-005	7932273*PED	2026-03-07	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-006	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214358-006	7932273*PED	2026-03-07	Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214358-001	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-001	7932273*PED	2026-03-07	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-002	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-002	7932273*PED	2026-03-07	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-003	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-003	7932273*PED	2026-03-07	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-004	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-004	7932273*PED	2026-03-07	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-005	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-005	7932273*PED	2026-03-07	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-006	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214358-006	7932273*PED	2026-03-07	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-001	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-001	7932273*PED	2026-03-07	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-002	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-002	7932273*PED	2026-03-07	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-003	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-003	7932273*PED	2026-03-07	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-004	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-004	7932273*PED	2026-03-07	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-005	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-005	7932273*PED	2026-03-07	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-006	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214358-006	7932273*PED	2026-03-07	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214358-001	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214358-001	7932273*PED	2026-03-07	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214358-002	7932273	2025-09-07	Drug substance, Drug product	2021-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214358-002	7932273*PED	2026-03-07	Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-001	NP	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-001	PED	2024-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-002	NP	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-002	PED	2024-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-003	NP	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-003	PED	2024-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-004	NP	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-004	PED	2024-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-005	NP	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-005	PED	2024-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-006	NP	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214358-006	PED	2024-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-001	NP	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-001	PED	2024-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-002	NP	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-002	PED	2024-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-003	NP	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-003	PED	2024-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-004	NP	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-004	PED	2024-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-005	NP	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-005	PED	2024-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-006	NP	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214358-006	PED	2024-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-001	NP	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-001	PED	2024-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-002	NP	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-002	PED	2024-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-003	NP	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-003	PED	2024-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-004	NP	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-004	PED	2024-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-005	NP	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-005	PED	2024-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-006	NP	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214358-006	PED	2024-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214358-001	NP	2024-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214358-001	PED	2024-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214358-002	NP	2024-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214358-002	PED	2024-12-21	`d8e5a09893c0…`

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
Pradaxa	DABIGATRAN ETEXILATE	Boehringer Ingelheim Pharmaceuticals, Inc.	9ac0a64a-8666-45f7-9d4f-40fd894f7e6d	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214358 application number: NDA214358 ndc (product): 0597-0430 ndc (product): 0597-0435 ndc (product): 0597-0425 ndc (product): 0597-0445 ndc (product): 0597-0450 ndc (product): 0597-0440

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0425	Pradaxa	DABIGATRAN ETEXILATE MESYLATE	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0425	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0425	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0430	Pradaxa	DABIGATRAN ETEXILATE MESYLATE	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0430	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0430	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0435	Pradaxa	DABIGATRAN ETEXILATE MESYLATE	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0435	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0435	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0440	Pradaxa	DABIGATRAN ETEXILATE MESYLATE	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0440	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0440	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0445	Pradaxa	DABIGATRAN ETEXILATE MESYLATE	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0445	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0445	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0450	Pradaxa	DABIGATRAN ETEXILATE MESYLATE	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0450	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0450	Pradaxa	dabigatran etexilate	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83643	SUPPL	2025-10-03
82604	SUPPL	2025-10-03
82605	SUPPL	2025-06-20
76575	SUPPL	2023-11-15
76570	SUPPL	2023-11-15
70698	SUPPL	2022-04-05
70697	SUPPL	2022-04-05
70678	ORIG	2022-04-01
70630	SUPPL	2022-03-28
67871	ORIG	2021-06-23
67847	ORIG	2021-06-22
67846	ORIG	2021-06-22