Application 207497

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

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

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

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	Approval date
A207497-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30
A207497-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207497-001	AB
A207497-002	AB
A207497-003	AB
A207497-004	AB
A207497-005	AB
A207497-006	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 7 · 258 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
2026-09-14 22:38:34	2026-08	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207497-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207497-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207497-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207497-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207497-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207497-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207497-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207497-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207497-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207497-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207497-004	AB	1	`b8a1b40f171c…`

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 LLC	0833d3df-2df1-4abd-abe0-7fb2c0253c80	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207497 application number: ANDA207497 ndc (product): 65162-986 ndc (product): 65162-988 ndc (product): 65162-949 ndc (product): 65162-958 ndc (product): 65162-956 ndc (product): 65162-990
Lamotrigine	LAMOTRIGINE	AvKARE	a63e19c0-a093-e896-e053-2a95a90a7ccd	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207497 application number: ANDA207497 ndc (product): 42291-448 ndc (product): 42291-444 ndc (product): 42291-446 ndc (product): 42291-445 ndc (product): 42291-443 ndc (product): 42291-447

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
42291-443	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-443	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-444	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-444	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-445	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-445	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-446	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-446	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-447	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-447	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-448	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-448	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
70518-3187	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current