Application 200694

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	25MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	100MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	150MG	No	No
004	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A200694-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14
A200694-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14
A200694-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14
A200694-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200694-001	AB
A200694-002	AB
A200694-003	AB
A200694-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200694-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2013-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200694-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2013-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200694-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2013-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200694-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2013-06-14	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200694-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200694-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200694-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200694-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200694-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200694-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200694-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200694-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200694-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200694-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200694-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200694-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200694-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200694-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200694-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200694-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200694-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200694-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200694-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200694-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200694-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200694-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200694-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200694-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200694-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200694-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200694-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200694-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200694-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200694-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200694-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200694-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200694-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200694-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200694-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200694-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200694-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200694-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200694-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200694-004	AB	1	`d8e5a09893c0…`

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
Lamotrigine	LAMOTRIGINE	Ascend Laboratories, LLC	70cd448a-2921-4c69-bdf2-5a6ce883bd07	2022-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200694 application number: ANDA200694 ndc (product): 67877-164 ndc (product): 67877-167 ndc (product): 67877-165 ndc (product): 67877-166

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-164	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-164	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-164	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-165	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-165	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-165	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-166	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-166	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-166	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-167	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-167	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current
67877-167	Lamotrigine	Lamotrigine	Ascend Laboratories, LLC	ANDA	Current