Application 204855

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

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
A204855-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05
A204855-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05
A204855-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05
A204855-004	LACOSAMIDE	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05

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 2 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204855-001	LACOSAMIDE	50MG	TABLET / ORAL	2023-01-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204855-002	LACOSAMIDE	100MG	TABLET / ORAL	2023-01-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204855-003	LACOSAMIDE	150MG	TABLET / ORAL	2023-01-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204855-004	LACOSAMIDE	200MG	TABLET / ORAL	2023-01-05	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204855-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204855-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204855-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204855-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204855-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204855-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204855-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204855-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204855-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204855-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204855-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204855-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204855-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204855-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204855-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204855-004	AB	1	`3bdfa0b2c4d7…`

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 4 · 67 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide Oral Solution	LACOSAMIDE	AvKARE	5b10986e-0809-b6d1-e063-6394a90a5738	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Novadoz Pharmaceuticals LLC	b9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Westminster Pharmaceuticals, LLC	ecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb86	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Glenmark Pharmaceuticals Limited	458e80da-8fc1-4715-9b4b-bc4f388f933f	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	REMEDYREPACK INC.	edd20b60-6265-4c4e-a95a-aaf8103cd852	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Fosun Pharma USA	ec1c5ddb-1143-7e6a-e053-2995a90a8382	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Gland Pharma Limited	779d2381-f590-45f9-a191-f44af821f4c8	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Aurobindo Pharma Limited	6140b3f1-ff60-427c-91d7-15af99fd78f1	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Aurobindo Pharma Limited	614490ce-a62c-4222-8e4b-ce802cf63028	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Camber Pharmaceuticals, Inc.	c5b91128-f838-4e98-9684-5f477fc7af06	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Zydus Pharmaceuticals USA Inc.	16a9afd2-35a6-44a9-b1d9-ca195c8640d7	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Major Pharmaceuticals	c83d2156-4dde-4316-98f1-b3dc751f3eac	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	NorthStar Rx LLC	48fcaa27-baaa-446e-a282-0c3e232cd151	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Dr. Reddy's Laboratories Inc.	cd5ac33e-6ac5-772b-2ead-d66cbd5bd1b4	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
Vimpat	LACOSAMIDE	UCB, Inc.	9e79b42c-38a3-4b2c-a196-a5a1948250e2	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Zydus Pharmaceuticals USA Inc.	07356cf2-224b-40d2-b827-e10a6b42c232	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Bryant Ranch Prepack	024bca92-cac5-4832-a1ff-c1b3d5994ba0	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Camber Pharmaceuticals, Inc.	e24d3c45-a559-4fca-a7be-74ce37a7066e	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	Clinical Solutions Wholesale, LLC	264c3718-67ea-4483-b036-2514c853635a	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	American Health Packaging	19060029-c158-4a37-9261-cfe3b2b5b1e3	2026-03-06	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52758	ORIG	2018-02-28