Application 214567

Type: ANDA
Sponsor: APOTEX

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 43.

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
A214567-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23
A214567-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23
A214567-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23
A214567-004	LACOSAMIDE	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23

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 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214567-001	LACOSAMIDE	50MG	TABLET / ORAL	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214567-002	LACOSAMIDE	100MG	TABLET / ORAL	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214567-003	LACOSAMIDE	150MG	TABLET / ORAL	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214567-004	LACOSAMIDE	200MG	TABLET / ORAL	2022-09-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A214567-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214567-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214567-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214567-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214567-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214567-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214567-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214567-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214567-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214567-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214567-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214567-004	AB	1	`f41ea6bd6efb…`

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 3 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide	LACOSAMIDE	American Health Packaging	f9aa6154-5d80-4597-90c3-cec131b455d4	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Coupler LLC	2d999f1f-11c6-bc28-e063-6394a90a4a52	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide Oral Solution	LACOSAMIDE	Chartwell RX, LLC	7197c0b6-5bb9-43b3-be1d-e7615629df9a	2025-02-12	Warnings, Adverse reactions	Name fallback generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Florida Pharmaceutical Products, LLC	3680c0ff-7f5c-4572-b1eb-4fea96b7fbe2	2025-02-12	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Fresenius Kabi USA, LLC	419ff519-2b19-4fb9-adfa-868ba0229407	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Golden State Medical Supply, Inc.	f047077c-2ac7-30d0-e053-2995a90ae429	2025-01-27	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Novadoz Pharmaceuticals LLC	a024081a-e131-4e88-967d-40155651a945	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Marlex Pharmaceuticals, Inc	0a273024-c2d2-4fae-90c3-b2f38a323f24	2024-12-15	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Leading Pharma, LLC	45786c84-51ef-4440-bc88-2501951e4c41	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Trigen Laboratories, LLC	d98ec7ed-353f-4d4f-9ccd-57ddc62edd0d	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Somerset Therapeutics, LLC	00203a7b-e774-45f7-ac6b-48db6d32a48a	2024-10-16	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Sun Pharmaceutical Industries, Inc.	2098d3a5-776e-4b52-8ade-80a3ab7b3de7	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Unichem Pharmaceuticals (USA), Inc.	7ed5cebe-470e-48a4-86ec-2ce79cc32688	2024-09-17	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	f7ea3ce6-4ca7-4405-a011-48e7d71360a5	2024-09-12	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	NorthStar RxLLC	e969b294-48d9-42a2-a093-0ac715142460	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Major Pharmaceuticals	973cea8d-e516-4014-a116-c5990554a550	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Macleods Pharmaceuticals Limited	035d85e5-8688-4390-bd55-74baa91c0e9d	2024-06-04	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	PAI Holdings, LLC dba PAI Pharma	75de00d8-d2e7-4025-be4e-f49299068e7e	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Amneal Pharmaceuticals of New York LLC	0e21389b-2f51-4975-aa21-fc5c9dd9f6dc	2024-05-17	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Proficient Rx LP	47ae2f1f-d135-4f4e-acc2-500c1afa7b8b	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.