Application 022251

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMICTAL ODT	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	25MG	Yes	No
002	LAMICTAL ODT	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	50MG	Yes	Yes
003	LAMICTAL ODT	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	100MG	Yes	No
004	LAMICTAL ODT	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	200MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS	Approval date
N022251-001	LAMICTAL ODT	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08
N022251-002	LAMICTAL ODT	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08
N022251-003	LAMICTAL ODT	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08
N022251-004	LAMICTAL ODT	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022251-001	AB
N022251-002	AB
N022251-003	AB
N022251-004	AB

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022251-001	LAMICTAL ODT	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022251-002	LAMICTAL ODT	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2009-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022251-003	LAMICTAL ODT	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022251-004	LAMICTAL ODT	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2009-05-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022251-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022251-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022251-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022251-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022251-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022251-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022251-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022251-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022251-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022251-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022251-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022251-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022251-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022251-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022251-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022251-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022251-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022251-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022251-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022251-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022251-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022251-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022251-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022251-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022251-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022251-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022251-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022251-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022251-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022251-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022251-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022251-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022251-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022251-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022251-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022251-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022251-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022251-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022251-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022251-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022251-001	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022251-001	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022251-001	7919115	2029-01-04		Drug substance, Drug product	2011-04-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022251-004	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022251-004	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022251-004	7919115	2029-01-04		Drug substance, Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022251-001	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022251-001	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022251-001	7919115	2029-01-04		Drug substance, Drug product	2011-04-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022251-004	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022251-004	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022251-004	7919115	2029-01-04		Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022251-001	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022251-001	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022251-001	7919115	2029-01-04		Drug substance, Drug product	2011-04-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022251-004	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022251-004	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022251-004	7919115	2029-01-04		Drug substance, Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022251-001	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022251-001	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022251-001	7919115	2029-01-04		Drug substance, Drug product	2011-04-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022251-004	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022251-004	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022251-004	7919115	2029-01-04		Drug substance, Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022251-001	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022251-001	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022251-001	7919115	2029-01-04		Drug substance, Drug product	2011-04-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022251-004	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022251-004	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022251-004	7919115	2029-01-04		Drug substance, Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022251-001	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022251-001	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022251-001	7919115	2029-01-04		Drug substance, Drug product	2011-04-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022251-004	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022251-004	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022251-004	7919115	2029-01-04		Drug substance, Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022251-001	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022251-001	9339504	2028-07-02	U-1596	Drug product	2016-06-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022251-001	7919115	2029-01-04		Drug substance, Drug product	2011-04-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022251-004	8840925	2028-07-02	U-1596	Drug product	2014-10-22	`87673890dc5c…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMICTAL	LAMOTRIGINE	GlaxoSmithKline LLC	d7e3572d-56fe-4727-2bb4-013ccca22678	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022251 application number: NDA022251 ndc (product): 0173-0772 ndc (product): 0173-0779 ndc (product): 0173-0774 ndc (product): 0173-0776 ndc (product): 0173-0778 ndc (product): 0173-0780 ndc (product): 0173-0777

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0772	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0772	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0772	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0772	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0772	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0772	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0772	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0774	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0774	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0774	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0774	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0774	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0774	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0774	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0776	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0776	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0776	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0776	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0776	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0776	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0776	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0777	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0777	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0777	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0777	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0777	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0777	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0777	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0778	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0778	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0778	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0778	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0778	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0778	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0778	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0779	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0779	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0779	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0779	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0779	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0779	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0779	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0780	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0780	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0780	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0780	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0780	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0780	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0780	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83767	SUPPL	2025-10-15
83766	SUPPL	2025-10-15
83743	SUPPL	2025-10-14
83742	SUPPL	2025-10-14
83741	SUPPL	2025-10-14
82117	SUPPL	2025-05-01
82116	SUPPL	2025-05-01
82049	SUPPL	2025-04-29
82048	SUPPL	2025-04-29
66970	SUPPL	2021-04-01
66969	SUPPL	2021-04-01
66942	SUPPL	2021-04-01
64916	SUPPL	2020-10-14
64915	SUPPL	2020-10-14
64902	SUPPL	2020-10-14
64560	SUPPL	2020-09-11
64559	SUPPL	2020-09-11
64516	SUPPL	2020-09-04
64472	SUPPL	2020-09-01
64313	SUPPL	2020-08-19
60134	SUPPL	2019-09-26
60133	SUPPL	2019-09-26
60119	SUPPL	2019-09-26
59718	SUPPL	2019-08-15
59711	SUPPL	2019-08-15
54984	SUPPL	2018-07-26
54983	SUPPL	2018-07-26
54962	SUPPL	2018-07-24
54843	SUPPL	2018-07-06
54757	SUPPL	2018-07-05
17132	SUPPL	2015-05-21
29454	SUPPL	2015-05-20
38428	SUPPL	2015-03-25
17128	SUPPL	2015-03-25
7096	SUPPL	2015-03-25
7092	SUPPL	2015-03-25
29449	SUPPL	2015-01-07
7093	SUPPL	2015-01-07
38427	SUPPL	2015-01-05
17126	SUPPL	2015-01-05
38429	SUPPL	2014-06-30
29453	SUPPL	2014-06-12
29448	SUPPL	2013-12-26
38425	SUPPL	2013-12-23
17131	SUPPL	2012-08-02
7095	SUPPL	2012-08-02
29452	SUPPL	2011-12-02
17130	SUPPL	2011-12-02
7094	SUPPL	2011-08-08
17129	SUPPL	2011-08-05
29451	SUPPL	2011-06-02
29450	SUPPL	2010-11-03
7091	SUPPL	2010-11-03
38426	SUPPL	2010-10-28
17127	SUPPL	2010-10-28
44715	ORIG	2010-05-27
42466	ORIG	2010-05-27
17125	ORIG	2009-07-08
29447	ORIG	2009-05-13
51220	SUPPL	1900-01-01
51219	SUPPL	1900-01-01
51218	SUPPL	1900-01-01