Application 208040

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A208040-001	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11
A208040-002	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11
A208040-003	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208040-001	AB
A208040-002	AB
A208040-003	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	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`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	A208040-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208040-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208040-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208040-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208040-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208040-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208040-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208040-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208040-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208040-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208040-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208040-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208040-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208040-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208040-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208040-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208040-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208040-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208040-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dabigatran Etexilate	DABIGATRAN ETEXILATE	A-S Medication Solutions	b31d27e9-5502-43c5-83fa-89608c014b7a	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208040 application number: ANDA208040
Dabigatran Etexilate	DABIGATRAN ETEXILATE	A-S Medication Solutions	369b945d-5bda-4773-910a-d0adef7f0f39	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208040 application number: ANDA208040
Dabigatran Etexilate	DABIGATRAN ETEXILATE	Ascend Laboratories, LLC	3a8ec82a-c367-40dc-9302-e1896fcb05ea	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208040 application number: ANDA208040 ndc (product): 67877-475 ndc (product): 67877-474
Dabigatran Etexilate	DABIGATRAN ETEXILATE	Major Pharmaceuticals	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208040 application number: ANDA208040

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-474	Dabigatran Etexilate	Dabigatran Etexilate	Ascend Laboratories, LLC	ANDA	Current
67877-474	Dabigatran Etexilate	Dabigatran Etexilate	Ascend Laboratories, LLC	ANDA	Current
67877-474	Dabigatran Etexilate	Dabigatran Etexilate	Ascend Laboratories, LLC	ANDA	Current
67877-475	Dabigatran Etexilate	Dabigatran Etexilate	Ascend Laboratories, LLC	ANDA	Current
67877-475	Dabigatran Etexilate	Dabigatran Etexilate	Ascend Laboratories, LLC	ANDA	Current
67877-475	Dabigatran Etexilate	Dabigatran Etexilate	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62987	ORIG	2020-05-14