Application 022115

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMICTAL XR	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	25MG	Yes	No
002	LAMICTAL XR	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	50MG	Yes	Yes
003	LAMICTAL XR	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	No
004	LAMICTAL XR	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	200MG	Yes	Yes
005	LAMICTAL XR	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	300MG	Yes	No
006	LAMICTAL XR	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	250MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022115-001	LAMICTAL XR	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29
N022115-002	LAMICTAL XR	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29
N022115-003	LAMICTAL XR	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29
N022115-004	LAMICTAL XR	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29
N022115-005	LAMICTAL XR	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14
N022115-006	LAMICTAL XR	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N022115-001	AB
N022115-002	AB
N022115-003	AB
N022115-004	AB
N022115-005	AB
N022115-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022115-001	8637512	2029-01-07	Drug product	2014-02-12
N022115-002	8637512	2029-01-07	Drug product	2014-02-12
N022115-003	8637512	2029-01-07	Drug product	2014-02-12
N022115-004	8637512	2029-01-07	Drug product	2014-02-12
N022115-005	8637512	2029-01-07	Drug product	2014-02-12
N022115-006	8637512	2029-01-07	Drug product	2014-02-12

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 7 · 246 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	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-005	LAMICTAL XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2010-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-006	LAMICTAL XR	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2011-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-001	LAMICTAL XR	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-002	LAMICTAL XR	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-003	LAMICTAL XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-004	LAMICTAL XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-05-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	N022115-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022115-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-004	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 390 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022115-001	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-002	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-003	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-004	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-005	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022115-006	8637512	2029-01-07	Drug product	2014-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-001	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-002	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-003	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-004	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-005	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022115-006	8637512	2029-01-07	Drug product	2014-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022115-001	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-002	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-003	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-004	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-005	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022115-006	8637512	2029-01-07	Drug product	2014-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-001	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-002	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-003	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-004	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-005	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022115-006	8637512	2028-06-14	Drug product	2014-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-001	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-002	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-003	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-004	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-005	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022115-006	8637512	2028-06-14	Drug product	2014-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-001	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-002	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-003	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-004	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-005	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022115-006	8637512	2028-06-14	Drug product	2014-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-001	8637512	2028-06-14	Drug product	2014-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-002	8637512	2028-06-14	Drug product	2014-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-003	8637512	2028-06-14	Drug product	2014-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022115-004	8637512	2028-06-14	Drug product	2014-02-12	`2680178bc6a6…`

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 XR	LAMOTRIGINE	GlaxoSmithKline LLC	3e2c9a35-6a39-41d7-ad84-3c0bb8894b09	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022115 application number: NDA022115 ndc (product): 0173-0758 ndc (product): 0173-0759 ndc (product): 0173-0761 ndc (product): 0173-0760 ndc (product): 0173-0754 ndc (product): 0173-0781 ndc (product): 0173-0756 ndc (product): 0173-0757 ndc (product): 0173-0755

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 63 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0754	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0754	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0754	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0754	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0754	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0754	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0754	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0755	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0755	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0755	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0755	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0755	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0755	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0755	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0756	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0756	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0756	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0756	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0756	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0756	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0756	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0757	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0757	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0757	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0757	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0757	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0757	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0757	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0758	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0758	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0758	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0758	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0758	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0758	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0758	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0759	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0759	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0759	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0759	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0759	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0759	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0759	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0760	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0760	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0760	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0760	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0760	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0760	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0760	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0761	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0761	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0761	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0761	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0761	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0761	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0761	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0781	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0781	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0781	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0781	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0781	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0781	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current
0173-0781	LAMICTAL	lamotrigine	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83765	SUPPL	2025-10-15
83764	SUPPL	2025-10-15
83734	SUPPL	2025-10-14
83733	SUPPL	2025-10-14
83732	SUPPL	2025-10-14
82115	SUPPL	2025-05-01
82114	SUPPL	2025-05-01
82053	SUPPL	2025-04-29
82052	SUPPL	2025-04-29
66964	SUPPL	2021-04-01
66963	SUPPL	2021-04-01
66943	SUPPL	2021-04-01
64910	SUPPL	2020-10-14
64909	SUPPL	2020-10-14
64903	SUPPL	2020-10-14
64517	SUPPL	2020-09-04
64473	SUPPL	2020-09-01
60136	SUPPL	2019-09-26
60135	SUPPL	2019-09-26
60120	SUPPL	2019-09-26
59720	SUPPL	2019-08-15
59712	SUPPL	2019-08-15
54977	SUPPL	2018-07-26
54961	SUPPL	2018-07-24
54844	SUPPL	2018-07-06
54756	SUPPL	2018-07-05
50608	SUPPL	2017-12-06
38268	SUPPL	2015-03-25
29270	SUPPL	2015-03-25
16970	SUPPL	2015-03-25
6920	SUPPL	2015-03-25
16967	SUPPL	2015-01-08
16964	SUPPL	2015-01-08
6918	SUPPL	2015-01-07
6916	SUPPL	2015-01-07
38271	SUPPL	2014-06-30
29273	SUPPL	2014-06-12
6915	SUPPL	2013-12-26
38265	SUPPL	2013-12-23
29272	SUPPL	2012-08-02
16969	SUPPL	2012-08-02
38270	SUPPL	2011-12-08
29271	SUPPL	2011-12-02
6917	SUPPL	2011-08-08
38269	SUPPL	2011-08-05
16968	SUPPL	2011-06-29
6919	SUPPL	2011-06-27
29269	SUPPL	2011-04-28
38266	SUPPL	2011-04-25
38267	SUPPL	2010-10-26
16966	SUPPL	2010-10-26
38264	SUPPL	2010-04-19
29268	SUPPL	2010-04-19
16965	SUPPL	2010-04-19
6914	SUPPL	2010-04-19
42420	ORIG	2010-02-14
24243	ORIG	2010-02-14
38263	ORIG	2009-06-10
6913	ORIG	2009-06-10
53307	SUPPL	1900-01-01
53306	SUPPL	1900-01-01
53305	SUPPL	1900-01-01
53304	ORIG	1900-01-01
53303	ORIG	1900-01-01
53302	ORIG	1900-01-01