Application 077783

Type: ANDA
Sponsor: CIPLA

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	Approval date
A077783-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01
A077783-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01
A077783-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01
A077783-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077783-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077783-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077783-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077783-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-004	AB	1	`ea99ee380514…`

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 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Cardinal Health 107, LLC	beb24a4f-ab0b-435a-b60b-2b8d565ecd75	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Cardinal Health 107, LLC	20e156df-a2b6-4710-b526-0419cd17dd33	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals LLC	0833d3df-2df1-4abd-abe0-7fb2c0253c80	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	A-S Medication Solutions	6139a858-700c-4eb9-9f84-99d280bde326	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Dr. Reddys Laboratories Inc.	54ea1ec3-876b-4d3a-a92b-1a6d70951de0	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	Golden State Medical Supply, Inc.	57f04b9b-06cd-8044-e063-6394a90ae733	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	American Health Packaging	35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	50d46278-636a-470e-afcc-d3c8bd844e46	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Inc.	60958229-5b5f-49e2-97f4-a8722138f7ce	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	1d7c2d52-a78e-4508-8853-ba306cdeeaba	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	15d801a0-f0a5-40c1-bc88-d5ba9a02c696	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	d1691a60-ff0a-4755-b445-1d78309d5af0	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	346f8af3-b850-48e4-bd6e-82ecafca86d2	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	f5761818-4eaf-4335-a77a-9cd703278ded	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	fa679e97-3b3d-4bf2-8de7-da3a89e38b37	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	Torrent Pharmaceuticals Limited	22225cc4-028e-43ad-8e1f-dcebdc244ecb	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	6ef17301-6c0b-4941-a84d-12243875d2e2	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	1b5646a9-4724-44b8-8cd0-9c14f5e87f86	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
LAMOTRIGINE	LAMOTRIGINE	Torrent Pharmaceuticals Limited	3448839b-4933-4ef9-a80a-9e504d2c5696	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LAMOTRIGINE generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Coupler LLC	55f41c7e-03a6-b84c-e063-6294a90a7d82	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE

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 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2466	LAMOTRIGINE	Lamotrigine	A-S Medication Solutions	ANDA	Current
50090-3171	LAMOTRIGINE	Lamotrigine	A-S Medication Solutions	ANDA	Current
50090-3171	LAMOTRIGINE	Lamotrigine	A-S Medication Solutions	ANDA	Current
50090-3278	LAMOTRIGINE	Lamotrigine	A-S Medication Solutions	ANDA	Current
50436-0149	LAMOTRIGINE	Lamotrigine	Unit Dose Services	ANDA	Current
53002-1512	LAMOTRIGINE	Lamotrigine	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1512	LAMOTRIGINE	Lamotrigine	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1513	LAMOTRIGINE	Lamotrigine	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1513	LAMOTRIGINE	Lamotrigine	RPK Pharmaceuticals, Inc.	ANDA	Current
58118-2148	LAMOTRIGINE	Lamotrigine	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-2148	LAMOTRIGINE	Lamotrigine	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-2148	LAMOTRIGINE	Lamotrigine	Clinical Solutions Wholesale, LLC	ANDA	Current
60760-549	LAMOTRIGINE	Lamotrigine	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-744	LAMOTRIGINE	Lamotrigine	Proficient Rx LP	ANDA	Current
63187-744	LAMOTRIGINE	Lamotrigine	Proficient Rx LP	ANDA	Current
68788-6822	LAMOTRIGINE	Lamotrigine	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-6822	LAMOTRIGINE	Lamotrigine	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-7178	LAMOTRIGINE	Lamotrigine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7178	LAMOTRIGINE	Lamotrigine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7278	LAMOTRIGINE	Lamotrigine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7278	LAMOTRIGINE	Lamotrigine	Preferred Pharmaceuticals Inc.	ANDA	Current
69097-148	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-148	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-148	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-148	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-149	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-149	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-149	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-149	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-151	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-151	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-151	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-151	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-152	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-152	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-152	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
69097-152	LAMOTRIGINE	Lamotrigine	Cipla USA Inc.	ANDA	Current
70518-0001	LAMOTRIGINE	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-0001	LAMOTRIGINE	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1480	LAMOTRIGINE	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1480	LAMOTRIGINE	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1602	LAMOTRIGINE	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1602	LAMOTRIGINE	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
71335-0010	LAMOTRIGINE	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
71335-0044	LAMOTRIGINE	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
71335-0044	LAMOTRIGINE	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
71335-0057	LAMOTRIGINE	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
71335-0276	LAMOTRIGINE	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
71335-0276	LAMOTRIGINE	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
76519-1150	LAMOTRIGINE	LAMOTRIGINE	H. J. Harkins Company Inc.	ANDA	Current
76519-1151	LAMOTRIGINE	LAMOTRIGINE	H. J. Harkins Company Inc.	ANDA	Current
76519-1165	LAMOTRIGINE	LAMOTRIGINE	H. J. Harkins Company Inc.	ANDA	Current