Application 214695

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACOSAMIDE	LACOSAMIDE	UNKNOWN	UNKNOWN	No	No
002	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	100MG	No	No
003	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	150MG	No	No
004	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214695-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31
A214695-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31
A214695-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31
A214695-004	LACOSAMIDE	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214695-001	AB
A214695-002	AB
A214695-003	AB
A214695-004	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 4 · 124 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
2026-08-18 06:07:40	2026-07	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-31	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214695-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214695-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214695-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214695-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214695-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214695-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214695-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214695-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214695-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214695-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214695-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214695-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214695-004	AB	1	`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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide	LACOSAMIDE	REMEDYREPACK INC.	d823fbfa-8ff5-4ef8-84ce-fbe916d4e430	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695
Lacosamide	LACOSAMIDE	Major Pharmaceuticals	c83d2156-4dde-4316-98f1-b3dc751f3eac	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695 ndc (product): 0904-7244 ndc (product): 0904-7247 ndc (product): 0904-7246 ndc (product): 0904-7245
Lacosamide	LACOSAMIDE	American Health Packaging	19060029-c158-4a37-9261-cfe3b2b5b1e3	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695 ndc (product): 60687-687 ndc (product): 60687-698 ndc (product): 60687-676
Lacosamide	LACOSAMIDE	REMEDYREPACK INC.	8d2906e3-d059-425d-b971-29423963c2af	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695
Lacosamide	LACOSAMIDE	Ascend Laboratories, LLC	9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695 ndc (product): 67877-734 ndc (product): 67877-733 ndc (product): 67877-736 ndc (product): 67877-735
Lacosamide	LACOSAMIDE	Advanced Rx of Tennessee, LLC	325df1b7-4908-0c03-e063-6294a90ad844	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214695 application number: ANDA214695

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7244	Lacosamide	Lacosamide	Major Pharmaceuticals	ANDA	Current
0904-7245	Lacosamide	Lacosamide	Major Pharmaceuticals	ANDA	Current
0904-7246	Lacosamide	Lacosamide	Major Pharmaceuticals	ANDA	Current
0904-7247	Lacosamide	Lacosamide	Major Pharmaceuticals	ANDA	Current
60687-676	Lacosamide	Lacosamide	American Health Packaging	ANDA	Current
60687-687	Lacosamide	Lacosamide	American Health Packaging	ANDA	Current
60687-698	Lacosamide	Lacosamide	American Health Packaging	ANDA	Current
67877-733	Lacosamide	Lacosamide	Ascend Laboratories, LLC	ANDA	Current
67877-734	Lacosamide	Lacosamide	Ascend Laboratories, LLC	ANDA	Current
67877-735	Lacosamide	Lacosamide	Ascend Laboratories, LLC	ANDA	Current
67877-736	Lacosamide	Lacosamide	Ascend Laboratories, LLC	ANDA	Current