Application 078009

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET, CHEWABLE; ORAL	2MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET, CHEWABLE;ORAL	5MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET, CHEWABLE;ORAL	25MG	No	No

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

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
A078009-002	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-01-22
A078009-003	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078009-002	AB
A078009-003	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 · 84 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	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078009-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078009-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078009-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078009-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-01-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A078009-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078009-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078009-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078009-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078009-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078009-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078009-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078009-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078009-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078009-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078009-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078009-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078009-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078009-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078009-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078009-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078009-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078009-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078009-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078009-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078009-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078009-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078009-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078009-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078009-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078009-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078009-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078009-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078009-003	AB	1	`bb7c543d1eb4…`

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	Zydus Pharmaceuticals USA Inc.	e849033b-a3bc-408e-88de-7cd1d2660949	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078009 application number: ANDA078009 ndc (product): 68382-108 ndc (product): 68382-109
Lamotrigine	LAMOTRIGINE	Zydus Lifesciences Limited	0f2f7421-56d4-45d0-9d2d-dc1edaede039	2025-10-04		Exact identifier application applno (ANDA): 078009 application number: ANDA078009 ndc (product): 65841-690 ndc (product): 65841-689

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
65841-689	Lamotrigine	Lamotrigine	Zydus Lifesciences Limited	ANDA	Current
65841-689	Lamotrigine	Lamotrigine	Cadila Healthcare Limited	ANDA	Current
65841-689	Lamotrigine	Lamotrigine	Cadila Healthcare Limited	ANDA	Current
65841-689	Lamotrigine	Lamotrigine	Cadila Healthcare Limited	ANDA	Current
65841-690	Lamotrigine	Lamotrigine	Zydus Lifesciences Limited	ANDA	Current
65841-690	Lamotrigine	Lamotrigine	Cadila Healthcare Limited	ANDA	Current
65841-690	Lamotrigine	Lamotrigine	Cadila Healthcare Limited	ANDA	Current
65841-690	Lamotrigine	Lamotrigine	Cadila Healthcare Limited	ANDA	Current
68382-108	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-108	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-108	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-108	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-108	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-108	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-109	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-109	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-109	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-109	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-109	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-109	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22617	ORIG	2012-02-14