Application 204857

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	50MG	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	Approval date
A204857-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	2022-03-17
A204857-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	2022-03-17
A204857-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	2022-03-17
A204857-004	LACOSAMIDE	LACOSAMIDE	200MG	TABLET / ORAL	2022-03-17

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	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204857-001	LACOSAMIDE	50MG	TABLET / ORAL		2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204857-002	LACOSAMIDE	100MG	TABLET / ORAL		2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204857-003	LACOSAMIDE	150MG	TABLET / ORAL		2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204857-004	LACOSAMIDE	200MG	TABLET / ORAL		2022-03-17	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204857-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204857-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204857-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204857-004	AB	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A204857-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204857-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204857-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204857-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204857-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204857-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204857-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204857-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204857-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204857-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204857-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204857-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204857-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204857-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204857-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204857-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204857-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204857-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204857-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204857-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204857-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204857-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204857-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204857-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204857-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204857-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204857-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204857-004	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204857-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204857-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204857-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204857-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204857-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204857-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204857-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204857-004	AB	1	`1c564ffb4f44…`

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
Lacosamide	LACOSAMIDE	Amneal Pharmaceuticals of New York LLC	0e21389b-2f51-4975-aa21-fc5c9dd9f6dc	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204857 application number: ANDA204857

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-860	Lacosamide	Lacosamide	AvKARE	ANDA	Current
42291-861	Lacosamide	Lacosamide	AvKARE	ANDA	Current
42291-862	Lacosamide	Lacosamide	AvKARE	ANDA	Current
42291-863	Lacosamide	Lacosamide	AvKARE	ANDA	Current
65162-923	Lacosamide	Lacosamide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-923	Lacosamide	Lacosamide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-924	Lacosamide	Lacosamide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-924	Lacosamide	Lacosamide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-925	Lacosamide	Lacosamide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-925	Lacosamide	Lacosamide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-926	Lacosamide	Lacosamide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-926	Lacosamide	Lacosamide	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52759	ORIG	2018-02-28