Application 207961

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 75MG BASE	No	No
002	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 150MG BASE	No	No
003	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 110MG BASE	No	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	Approval date
A207961-001	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06
A207961-002	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06
A207961-003	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207961-001	AB
A207961-002	AB
A207961-003	AB

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 3 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`5c6f7cd8ea54…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207961-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207961-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207961-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207961-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207961-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207961-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207961-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207961-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207961-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207961-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207961-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207961-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207961-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207961-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207961-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207961-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207961-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207961-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207961-002	AB	1	`5c6f7cd8ea54…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dabigatran Etexilate	DABIGATRAN ETEXILATE	NorthStar RxLLC	d5937f27-88c7-4c4a-801e-4c8945008982	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207961 application number: ANDA207961
Dabigatran Etexilate	DABIGATRAN ETEXILATE	Camber Pharmaceuticals, Inc.	3c24e235-218b-438e-9456-42c18ff01913	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207961 application number: ANDA207961 ndc (product): 31722-622 ndc (product): 31722-621
Dabigatran Etexilate	DABIGATRAN ETEXILATE	XLCare Pharmaceuticals, Inc.	19b3bfc1-4fcb-4eb9-a611-02c27c05c56e	2023-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207961 application number: ANDA207961

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-621	Dabigatran Etexilate	Dabigatran Etexilate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-621	Dabigatran Etexilate	Dabigatran Etexilate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-622	Dabigatran Etexilate	Dabigatran Etexilate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-622	Dabigatran Etexilate	Dabigatran Etexilate	Camber Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63416	ORIG	2020-06-04