Application 078409

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET; ORAL	2MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET, CHEWABLE;ORAL	5MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET, CHEWABLE;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078409-002	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL			2009-01-22
A078409-003	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL			2009-01-22

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078409-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	2009-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078409-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	2009-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078409-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	2009-01-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078409-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	2009-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078409-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	2009-01-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078409-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	2009-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078409-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	2009-01-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078409-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	2009-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078409-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	2009-01-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078409-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	2009-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078409-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	2009-01-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078409-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	2009-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078409-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	2009-01-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078409-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	2009-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078409-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	2009-01-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078409-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	2009-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078409-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078409-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	2009-01-22	`f41ea6bd6efb…`

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 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Cardinal Health 107, LLC	beb24a4f-ab0b-435a-b60b-2b8d565ecd75	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Cardinal Health 107, LLC	20e156df-a2b6-4710-b526-0419cd17dd33	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals LLC	0833d3df-2df1-4abd-abe0-7fb2c0253c80	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	6139a858-700c-4eb9-9f84-99d280bde326	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Dr. Reddys Laboratories Inc.	54ea1ec3-876b-4d3a-a92b-1a6d70951de0	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	Golden State Medical Supply, Inc.	57f04b9b-06cd-8044-e063-6394a90ae733	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	American Health Packaging	35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	50d46278-636a-470e-afcc-d3c8bd844e46	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Inc.	60958229-5b5f-49e2-97f4-a8722138f7ce	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	1d7c2d52-a78e-4508-8853-ba306cdeeaba	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	15d801a0-f0a5-40c1-bc88-d5ba9a02c696	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	d1691a60-ff0a-4755-b445-1d78309d5af0	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	346f8af3-b850-48e4-bd6e-82ecafca86d2	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	f5761818-4eaf-4335-a77a-9cd703278ded	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	fa679e97-3b3d-4bf2-8de7-da3a89e38b37	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	Torrent Pharmaceuticals Limited	22225cc4-028e-43ad-8e1f-dcebdc244ecb	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	6ef17301-6c0b-4941-a84d-12243875d2e2	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	1b5646a9-4724-44b8-8cd0-9c14f5e87f86	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	Torrent Pharmaceuticals Limited	3448839b-4933-4ef9-a80a-9e504d2c5696	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Coupler LLC	55f41c7e-03a6-b84c-e063-6294a90a7d82	2026-07-06	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.