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 4 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide	LACOSAMIDE	Indoco Remedies Limited	ba337b2c-7c1f-4f7b-ba93-054f502400f3	2024-03-26	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Alembic Pharmaceuticals Inc.	07b7b3f2-16a0-4deb-883b-10522676d966	2023-11-09	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Zydus Lifesciences Limited	3bc84c70-bc1d-4a72-bbe7-86f32cd646d0	2023-10-03		Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Tris Pharma Inc	7f37f8b8-07d3-48c4-a0c4-7652b62a1ad9	2023-06-26	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Alembic Pharmaceuticals Limited	46b98d5e-fdb6-483a-b022-8b1f0aa832c5	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	XLCare Pharmaceuticals Inc.	c7793da3-787b-4364-9192-7caab49066f1	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
lacosamide	LACOSAMIDE	MSN LABORATORIES PRIVATE LIMITED	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2022-04-21		Name fallback brand name: lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Indoco Remedies Limited	145b4fae-ce6d-43e8-a474-fcb9dff92a53	2022-03-09	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.