Application 201168

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET, CHEWABLE;ORAL	5MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET, CHEWABLE;ORAL	25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201168-001	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB		2014-06-12
A201168-002	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB		2014-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201168-001	AB
A201168-002	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 3 · 82 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	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201168-001	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2014-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201168-002	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2014-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201168-001	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201168-002	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2014-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201168-001	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2014-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201168-002	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2014-06-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A201168-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201168-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201168-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201168-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201168-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201168-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201168-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201168-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201168-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201168-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201168-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201168-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201168-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201168-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201168-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201168-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201168-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201168-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201168-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201168-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201168-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201168-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201168-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201168-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201168-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201168-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201168-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201168-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201168-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201168-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201168-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201168-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201168-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201168-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201168-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201168-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201168-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201168-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201168-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201168-002	AB	1	`782e0a99824c…`

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	Alembic Pharmaceuticals Inc.	05cba628-b12c-44d8-89a8-3522fe417cc1	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201168 application number: ANDA201168 ndc (product): 62332-095 ndc (product): 62332-096
lamotrigine	LAMOTRIGINE CHEWABLE DISPERSIBLE	Alembic Pharmaceuticals Limited	ae6522d4-d824-44aa-afe0-70cdcbd845af	2023-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201168 application number: ANDA201168 ndc (product): 46708-095 ndc (product): 46708-096

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-095	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Limited	ANDA	Current
46708-095	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Limited	ANDA	Current
46708-096	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Limited	ANDA	Current
46708-096	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Limited	ANDA	Current
62332-095	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-095	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-095	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-095	lamotrigine	lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-095	lamotrigine	lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-095	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-095	lamotrigine	lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-095	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-096	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-096	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-096	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-096	lamotrigine	lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-096	lamotrigine	lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-096	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-096	lamotrigine	lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-096	lamotrigine	lamotrigine chewable dispersible	Alembic Pharmaceuticals Inc.	ANDA	Current