Application 078947

Type: ANDA
Sponsor: TORRENT PHARMS

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 1.

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
A078947-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A078947-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A078947-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A078947-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078947-001	AB
A078947-002	AB
A078947-003	AB
A078947-004	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 · 164 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	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A078947-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078947-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078947-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-004	AB	1	`d06236e962d9…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	1d7c2d52-a78e-4508-8853-ba306cdeeaba	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947 ndc (product): 70518-2755
LAMOTRIGINE	LAMOTRIGINE	Torrent Pharmaceuticals Limited	3448839b-4933-4ef9-a80a-9e504d2c5696	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	50d46278-636a-470e-afcc-d3c8bd844e46	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947 ndc (product): 70518-2889
LAMOTRIGINE	LAMOTRIGINE	PD-Rx Pharmaceuticals, Inc.	f31e1854-6068-4e45-b1e5-6def862fc466	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	PD-Rx Pharmaceuticals, Inc.	c638ab70-05dd-4f8b-9a11-b33a75f8c504	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE Kit	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	474fb321-575c-4b97-9dbe-080061652ee4	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947 ndc (product): 69102-639 ndc (product): 69102-359
SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	7ad18b68-ba16-4810-9c3e-27fa970454e8	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947 ndc (product): 69102-312 ndc (product): 69102-320 ndc (product): 69102-319
LAMOTRIGINE	LAMOTRIGINE	Northwind Health Company, LLC	f7587283-781b-e111-e053-6394a90ad4cc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	NuCare Pharmaceuticals,Inc.	1bbbe2a2-a9e8-8c13-e063-6394a90a9627	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	A-S Medication Solutions	4e6cc1ad-55cd-4c7f-878c-fa6716e95897	2023-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 112 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69102-312	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-319	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-319	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-319	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-319	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-320	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-320	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-320	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-320	SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-359	LAMOTRIGINE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-359	LAMOTRIGINE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-359	LAMOTRIGINE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-359	LAMOTRIGINE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-639	LAMOTRIGINE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-639	LAMOTRIGINE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-639	LAMOTRIGINE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
69102-639	LAMOTRIGINE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	ANDA	Current
70518-2645	SUBVENITE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2645	SUBVENITE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2645	SUBVENITE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2697	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2697	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2697	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2697	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2755	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2755	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2755	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2889	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
70518-2889	LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	ANDA	Current
71335-1579	LAMOTRIGINE	LAMOTRIGINE	Bryant Ranch Prepack	ANDA	Current
71335-1579	LAMOTRIGINE	LAMOTRIGINE	Bryant Ranch Prepack	ANDA	Current
71335-1579	LAMOTRIGINE	LAMOTRIGINE	Bryant Ranch Prepack	ANDA	Current