Application 090607

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;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 43.

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	RLD / RS	Approval date
A090607-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	RS	2011-01-13
A090607-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13
A090607-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13
A090607-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090607-001	AB
A090607-002	AB
A090607-003	AB
A090607-004	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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	RS	2011-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	RS	2011-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB		2011-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB		2011-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB		2011-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB		2011-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB		2011-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB		2011-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB		2011-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090607-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB		2011-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090607-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB		2011-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090607-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB		2011-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090607-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB		2011-01-13	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090607-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090607-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090607-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090607-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090607-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090607-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090607-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090607-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090607-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090607-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090607-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090607-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090607-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090607-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090607-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090607-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090607-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090607-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090607-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090607-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090607-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090607-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090607-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090607-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090607-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090607-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090607-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090607-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090607-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090607-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090607-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090607-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090607-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090607-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090607-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090607-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090607-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090607-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090607-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090607-004	AB	1	`74a2ff9319b5…`

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.	60958229-5b5f-49e2-97f4-a8722138f7ce	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090607 application number: ANDA090607 ndc (product): 62332-040 ndc (product): 62332-038 ndc (product): 62332-037 ndc (product): 62332-039
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Limited	ccb33cd0-e5f7-4a50-8b55-ad7c432cdb77	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090607 application number: ANDA090607 ndc (product): 46708-276 ndc (product): 46708-274 ndc (product): 46708-275 ndc (product): 46708-277

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 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-274	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-274	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-275	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-275	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-276	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-276	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-277	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-277	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
50090-2992	Lamotrigine	Lamotrigine	A-S Medication Solutions	ANDA	Current
55154-8129	Lamotrigine	Lamotrigine	Cardinal Health	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
63739-516	Lamotrigine	Lamotrigine	McKesson Corporation	ANDA	Current
63739-516	Lamotrigine	Lamotrigine	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-517	Lamotrigine	Lamotrigine	McKesson Corporation	ANDA	Current
63739-517	Lamotrigine	Lamotrigine	McKesson Corporation dba SKY Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9280	ORIG	2012-02-14