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 2 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	3ed4590d-71e3-4208-b6c0-98330acc7b85	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	de7f61ca-e3c0-4a09-b664-0df2de6a0c30	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Coupler LLC	545fcc0e-1e2b-bdcb-e063-6294a90a4ac7	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	b1601109-5c17-4482-9257-1e0be7546e8f	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	022b0913-f683-4af8-a862-f81b315909b2	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Sun Pharmaceutical Industries, Inc.	b829f9b2-f0ac-408a-a6f4-18b72150227d	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	68a4dac2-5015-40c5-88ca-204098c3b288	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Coupler LLC	52b8be5c-ef88-dfa7-e063-6394a90a0500	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Aurobindo Pharma Limited	a9a4309e-fe43-4a26-a30f-c6577d650336	2026-05-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Limited	ccb33cd0-e5f7-4a50-8b55-ad7c432cdb77	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Unichem Pharmaceuticals (USA), Inc.	4b72ea7a-a0b0-4980-84ad-84f64e2e6368	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals, Inc.	16323699-9bf8-43c7-b3aa-589156377872	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals Inc.	09a0d30d-9b8f-4c76-8cdb-8492386b2254	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	AvKARE	fcdb94a8-33be-6375-98ef-6933999d157f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Major Pharmaceuticals	12e0be85-0961-4fe0-b973-83251ecf0f65	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Actavis Pharma, Inc.	87beaf22-593d-4170-bb58-332c615ef90d	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	Sun Pharmaceutical Industries, Inc.	83297e2e-9199-4b3d-9f44-a921787758fe	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	REMEDYREPACK INC.	65748114-c59c-4ebb-977e-d4aab5764dd3	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamotrigine
Lamotrigine	LAMOTRIGINE	Par Health USA, LLC	003663e5-c0c7-4fc1-a64d-313f2a5b10d2	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Nordic Pharma, Inc.	67cf961e-02b9-4a99-944f-43a55df6a544	2026-04-07	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.