Application 200828

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	25MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	50MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	100MG	No	No
004	LAMOTRIGINE	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	200MG	No	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	Approval date
A200828-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15
A200828-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15
A200828-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15
A200828-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200828-001	AB
A200828-002	AB
A200828-003	AB
A200828-004	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200828-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200828-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200828-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200828-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-15	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 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	A200828-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200828-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200828-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200828-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200828-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200828-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200828-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200828-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200828-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200828-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200828-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200828-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200828-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200828-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200828-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200828-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200828-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200828-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200828-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200828-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200828-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200828-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200828-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200828-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200828-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200828-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200828-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200828-004	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200828-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200828-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200828-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200828-004	AB	1	`d8e5a09893c0…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200828-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200828-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200828-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200828-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200828-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200828-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200828-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200828-004	AB	1	`5d02ea3f76ae…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	9e5c2d76-47a6-4a57-b23c-2398b307380c	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200828 application number: ANDA200828 ndc (product): 0115-9941 ndc (product): 0115-9940 ndc (product): 0115-9942 ndc (product): 0115-9939
Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	380bddae-5b31-4965-96de-97711d859d11	2016-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200828 application number: ANDA200828 ndc (product): 0115-1528 ndc (product): 0115-1526 ndc (product): 0115-1529 ndc (product): 0115-1527

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1526	Lamotrigine	LAMOTRIGINE	Impax Generics	ANDA	Current
0115-1526	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1526	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1526	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1527	Lamotrigine	LAMOTRIGINE	Impax Generics	ANDA	Current
0115-1527	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1527	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1527	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1528	Lamotrigine	LAMOTRIGINE	Impax Generics	ANDA	Current
0115-1528	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1528	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1528	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1529	Lamotrigine	LAMOTRIGINE	Impax Generics	ANDA	Current
0115-1529	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1529	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1529	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9939	Lamotrigine	LAMOTRIGINE	Impax Generics	ANDA	Current
0115-9939	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9939	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9939	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9939	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9939	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9939	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9940	Lamotrigine	LAMOTRIGINE	Impax Generics	ANDA	Current
0115-9940	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9940	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9940	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9940	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9940	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9940	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9941	Lamotrigine	LAMOTRIGINE	Impax Generics	ANDA	Current
0115-9941	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9941	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9941	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9941	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9941	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9941	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9942	Lamotrigine	LAMOTRIGINE	Impax Generics	ANDA	Current
0115-9942	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9942	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9942	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9942	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9942	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9942	Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32068	ORIG	2013-07-17