Application 206355

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACOSAMIDE	LACOSAMIDE	SOLUTION;ORAL	10MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206355-001	LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION / ORAL			2022-09-26

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL		2022-09-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL		2022-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL		2022-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2022-09-26	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206355-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL		2022-09-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206355-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206355-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206355-001	AA	1	`6a471c1ec25d…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206355-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206355-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206355-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206355-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206355-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206355-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206355-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206355-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206355-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206355-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206355-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206355-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206355-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206355-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206355-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206355-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206355-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206355-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206355-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206355-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206355-001	AA	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.