Application 090401

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET; ORAL	5MG	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 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
A090401-002	LAMOTRIGINE	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-11-04
A090401-003	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB		2009-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090401-002	AB
A090401-003	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 · 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	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090401-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090401-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090401-002	LAMOTRIGINE	5MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090401-003	LAMOTRIGINE	25MG	TABLET, FOR SUSPENSION / ORAL	AB	2009-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090401-002	LAMOTRIGINE	5MG	TABLET, CHEWABLE / ORAL	AB	2009-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090401-003	LAMOTRIGINE	25MG	TABLET, CHEWABLE / ORAL	AB	2009-11-04	`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	A090401-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090401-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090401-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090401-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090401-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090401-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090401-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090401-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090401-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090401-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090401-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090401-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090401-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090401-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090401-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090401-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090401-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090401-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090401-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090401-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090401-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090401-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090401-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090401-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090401-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090401-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090401-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090401-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090401-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090401-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090401-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090401-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090401-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090401-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090401-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090401-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090401-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090401-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090401-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090401-003	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	Rising Pharma Holdings, Inc.	f54690b3-bcbb-4d94-95b9-b7591af00117	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090401 application number: ANDA090401 ndc (product): 16571-786 ndc (product): 16571-785
Lamotrigine	LAMOTRIGINE	Aurobindo Pharma Limited	e08920c2-04a3-4fb5-acc5-0af3140f82e9	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090401 application number: ANDA090401 ndc (product): 65862-361 ndc (product): 65862-362

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-785	Lamotrigine	Lamotrigine	Rising Pharma Holdings, Inc.	ANDA	Current
16571-785	Lamotrigine	Lamotrigine	Rising Pharma Holdings, Inc.	ANDA	Current
16571-786	Lamotrigine	Lamotrigine	Rising Pharma Holdings, Inc.	ANDA	Current
16571-786	Lamotrigine	Lamotrigine	Rising Pharma Holdings, Inc.	ANDA	Current
64980-400	Lamotrigine	Lamotrigine	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-400	Lamotrigine	Lamotrigine	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-400	Lamotrigine	Lamotrigine	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-400	Lamotrigine	Lamotrigine	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-401	Lamotrigine	Lamotrigine	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-401	Lamotrigine	Lamotrigine	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-401	Lamotrigine	Lamotrigine	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-401	Lamotrigine	Lamotrigine	Rising Pharmaceuticals, Inc.	ANDA	Current
65862-361	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-361	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-361	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-361	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-361	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-361	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-362	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-362	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-362	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-362	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-362	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current
65862-362	Lamotrigine	Lamotrigine	Aurobindo Pharma Limited	ANDA	Current