Application 200672

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

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	300MG	No	No
006	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	250MG	No	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	Approval date
A200672-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-005	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17
A200672-006	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200672-001	AB
A200672-002	AB
A200672-003	AB
A200672-004	AB
A200672-005	AB
A200672-006	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 6 · 238 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	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-006	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-10-17	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 238 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	A200672-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200672-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200672-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200672-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200672-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200672-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200672-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200672-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200672-004	AB	1	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Actavis Pharma, Inc.	87beaf22-593d-4170-bb58-332c615ef90d	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200672 application number: ANDA200672 ndc (product): 0228-1580 ndc (product): 0228-1453 ndc (product): 0228-1638 ndc (product): 0228-1435 ndc (product): 0228-1422 ndc (product): 0228-1410
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	36f383af-8b71-4875-85ef-3a7a8b1d8805	2024-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200672 application number: ANDA200672 ndc (product): 71335-1469

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-1410	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1410	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1410	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1410	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1410	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1410	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1410	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1410	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1422	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1422	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1422	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1422	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1422	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1422	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1422	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1422	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1435	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1435	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1435	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1435	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1435	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1435	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1435	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1435	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1453	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1453	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1453	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1453	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1453	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1453	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1453	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1453	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1580	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1580	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1580	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1580	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1580	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1580	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1580	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1580	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1638	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1638	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
70518-1181	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1181	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
71335-1469	Lamotrigine	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
71335-1469	Lamotrigine	Lamotrigine	Bryant Ranch Prepack	ANDA	Current