Application 077392

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	25MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	100MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	150MG	No	No
004	LAMOTRIGINE	LAMOTRIGINE	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
A077392-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27
A077392-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27
A077392-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27
A077392-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27

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 5 · 172 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	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077392-001	LAMOTRIGINE	25MG	TABLET / ORAL	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077392-002	LAMOTRIGINE	100MG	TABLET / ORAL	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077392-003	LAMOTRIGINE	150MG	TABLET / ORAL	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077392-004	LAMOTRIGINE	200MG	TABLET / ORAL	2009-01-27	`5bbf6a4d5a75…`

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 5 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	2cf33586-e48a-4b4e-b14b-33de2be63c1d	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	4bbc140c-6092-416d-865d-49b89c5ecdd0	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	cf03f130-067f-401c-8501-0d78a989a319	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	NuCare Pharmaceuticals,Inc.	065e97c9-3c5f-16e6-e063-6294a90a13fc	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	DIRECT RX	a835b697-2beb-1ba8-e053-2995a90a470c	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Advanced Rx Pharmacy of Tennessee, LLC	f7a86237-ece4-7cc4-e053-6294a90a1308	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Dr.Reddy's Laboratories Limited	44670496-41ea-36a1-c435-32e359766a74	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTIRIGINE	Zydus Lifesciences Limited	ecb7a528-699f-4e51-9887-dee60456da2f	2024-11-30		Name fallback brand name: Lamotrigine
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Limited	faee013c-cad2-4abb-904c-e6ff79ba778c	2024-10-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	NCS HealthCare of KY, LLC dba Vangard Labs	e243e803-e95f-47a6-a6da-5fed657f4462	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	NuCare Pharmaceuticals,Inc.	1bbbe2a2-a9e8-8c13-e063-6394a90a9627	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	36f383af-8b71-4875-85ef-3a7a8b1d8805	2024-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	ffa46cb2-16e7-45f3-9940-5cb88d0cda9d	2024-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	6f7e59d2-4311-42a0-93a0-b29b0417d96f	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	5a9575bb-230e-46ae-b58e-41554bad45eb	2023-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	Proficient Rx LP	39efe933-bfed-4a6a-b270-0883871c5186	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamotrigine
LAMOTRIGINE	LAMOTRIGINE	A-S Medication Solutions	4e6cc1ad-55cd-4c7f-878c-fa6716e95897	2023-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
lamotrigine	LAMOTRIGINE CHEWABLE DISPERSIBLE	Alembic Pharmaceuticals Limited	ae6522d4-d824-44aa-afe0-70cdcbd845af	2023-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamotrigine
Lamotrigine	LAMOTRIGINE	Ascend Laboratories, LLC	70cd448a-2921-4c69-bdf2-5a6ce883bd07	2022-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	ScieGen Pharmaceuticals, Inc.	de700ac1-4048-467e-abb1-238953261a97	2022-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE

Reported adverse events (FAERS/openFDA)#

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