Application 078525

Type: ANDA
Sponsor: TARO PHARM INDS

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
A078525-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A078525-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A078525-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A078525-004	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
A078525-001	AB
A078525-002	AB
A078525-003	AB
A078525-004	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	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078525-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-004	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	A078525-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078525-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078525-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078525-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078525-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078525-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078525-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078525-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078525-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078525-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078525-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078525-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078525-004	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Sun Pharmaceutical Industries, Inc.	b829f9b2-f0ac-408a-a6f4-18b72150227d	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078525 application number: ANDA078525 ndc (product): 51672-4130 ndc (product): 51672-4132 ndc (product): 51672-4133 ndc (product): 51672-4131
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	68a4dac2-5015-40c5-88ca-204098c3b288	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078525 application number: ANDA078525 ndc (product): 71335-2071
Lamotrigine	LAMOTRIGINE	NuCare Pharmaceuticals, Inc.	47fd2592-2fc6-9787-e063-6394a90a8f01	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078525 application number: ANDA078525

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-107	Lamotrigine	Lamotrigine	Rebel Distributors Corp	NDA	Current
21695-227	Lamotrigine	Lamotrigine	Rebel Distributors Corp	NDA	Current
21695-228	Lamotrigine	Lamotrigine	Rebel Distributors Corp	NDA	Current
21695-229	Lamotrigine	Lamotrigine	Rebel Distributors Corp	NDA	Current
35356-619	Lamotrigine	Lamotrigine	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-3098	Lamotrigine	Lamotrigine	A-S Medication Solutions	ANDA	Current
50090-3103	Lamotrigine	Lamotrigine	A-S Medication Solutions	ANDA	Current
51672-4130	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4130	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4130	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4130	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4130	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4131	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4131	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4131	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4131	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4131	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4132	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4132	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4132	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4132	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4132	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4133	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4133	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4133	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4133	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4133	Lamotrigine	Lamotrigine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
53808-1003	Lamotrigine	Lamotrigine	State of Florida DOH Central Pharmacy	ANDA	Current
60760-543	Lamotrigine	Lamotrigine	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
70518-1523	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1523	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1523	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1523	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1523	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2108	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2108	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2716	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2716	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2716	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2716	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2716	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2716	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-3150	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
71335-2071	Lamotrigine	Lamotrigine	Bryant Ranch Prepack	ANDA	Current