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 4 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMOTRIGINE	LAMOTRIGINE	Northwind Health Company, LLC	f7587283-781b-e111-e053-6394a90ad4cc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Northstar Rx LLC.	aabc64fe-1f17-4140-81f2-7d4506db6c8b	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	Yiling Pharmaceutical, Inc.	f7de11a5-5357-4753-b1ac-b15123b50028	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamotrigine
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	84277e2c-370c-4510-92bc-ef33a4a0f508	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	9e5c2d76-47a6-4a57-b23c-2398b307380c	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Ajanta Pharma USA Inc.	9dfb5f87-0150-4c26-a89f-34f1ab389500	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Dr.Reddy's Laboratories Limited	a69542ea-5b6f-15c1-9e7a-90ac839971d3	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	NorthStar Rx LLC	9ab07d6b-ae4a-a310-5572-b266676cd29e	2025-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Advagen Pharma Limited	4ca9d713-ab63-48bf-9386-29301a842e60	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Zydus Pharmaceuticals USA Inc.	e849033b-a3bc-408e-88de-7cd1d2660949	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Zydus Pharmaceuticals USA Inc.	eb436371-d188-4803-a864-07b90c357e57	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMICTAL	LAMOTRIGINE	GlaxoSmithKline LLC	d7e3572d-56fe-4727-2bb4-013ccca22678	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMOTRIGINE
LAMICTAL XR	LAMOTRIGINE	GlaxoSmithKline LLC	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Zydus Lifesciences Limited	0f2f7421-56d4-45d0-9d2d-dc1edaede039	2025-10-04		Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	8e1e4fa8-881c-4618-88f6-018ab15db44d	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	53774022-ea0c-42a9-a720-dc755c77b851	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Coupler LLC	3dfdcc2d-b7c5-7abf-e063-6394a90a24a6	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	d33c4293-347c-49a1-9d98-f291c3dab6da	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Jubilant Cadista Pharmacuticals Inc.	0b0f0209-edbd-46f3-9bed-762cbea0d737	2025-07-15	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.