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 3 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMOTRIGINE Kit	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	474fb321-575c-4b97-9dbe-080061652ee4	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	7ad18b68-ba16-4810-9c3e-27fa970454e8	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Limited	03610cdf-7eaa-445c-a441-ff17be5a7c68	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Rising Pharma Holdings, Inc.	f54690b3-bcbb-4d94-95b9-b7591af00117	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	260dc37d-6e64-4688-82dc-10a1a428af17	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Aurobindo Pharma Limited	e08920c2-04a3-4fb5-acc5-0af3140f82e9	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Torrent Pharmaceuticals Limited	52df02a7-83da-4b20-9951-69790237dc24	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Inc.	df34faa4-829e-413a-a230-cbec604eead9	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	American Health Packaging	6034a8b8-9e80-43ca-b84f-ea82f788268c	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Inc.	05cba628-b12c-44d8-89a8-3522fe417cc1	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Inc.	4bd7193f-a81a-4909-90c2-7f324fc6ddfd	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	Camber Pharmaceuticals Inc	e45bd69f-3580-ff15-e053-2a95a90a4615	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lamotrigine
Lamotrigine	LAMOTRIGINE	Glenmark Pharmaceuticals Inc., USA	50fcf452-2d21-493e-a1dd-0c6ea9ac6184	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine Extended-Release	LAMOTRIGINE	Par Health USA, LLC	d5ec4d58-c669-4ab4-ba62-b71007536854	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Preferred Pharmaceuticals Inc.	634dbe6c-4874-4d54-aa25-be02d3341f16	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	AvKARE	a63e19c0-a093-e896-e053-2a95a90a7ccd	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	NuCare Pharmaceuticals, Inc.	47fd2592-2fc6-9787-e063-6394a90a8f01	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Quallent Pharmaceuticals Health LLC	7977c87f-b459-486a-9edc-0a2071c46f4c	2026-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Northwind Health Company, LLC	03fd8413-df56-50ab-e063-6394a90a6950	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Northwind Health Company, LLC	db5f7ee5-9bd9-1819-e053-2a95a90a91df	2026-01-01	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.