Application 079132

Type: ANDA
Sponsor: JUBILANT CADISTA

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	TE codes	Approval date
A079132-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A079132-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A079132-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A079132-004	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
A079132-001	AB
A079132-002	AB
A079132-003	AB
A079132-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079132-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079132-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079132-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079132-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079132-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079132-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079132-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079132-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079132-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079132-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079132-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079132-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079132-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079132-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079132-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079132-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079132-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079132-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079132-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079132-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079132-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079132-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079132-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079132-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079132-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079132-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079132-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079132-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079132-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079132-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079132-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079132-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079132-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079132-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079132-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079132-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079132-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079132-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079132-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079132-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079132-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079132-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079132-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079132-004	AB	1	`5bbf6a4d5a75…`

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	AvKARE	fcdb94a8-33be-6375-98ef-6933999d157f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079132 application number: ANDA079132 ndc (product): 42291-367 ndc (product): 42291-366 ndc (product): 42291-368 ndc (product): 42291-369
Lamotrigine	LAMOTRIGINE	Bryant Ranch Prepack	d33c4293-347c-49a1-9d98-f291c3dab6da	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079132 application number: ANDA079132 ndc (product): 63629-4697
Lamotrigine	LAMOTRIGINE	Jubilant Cadista Pharmacuticals Inc.	0b0f0209-edbd-46f3-9bed-762cbea0d737	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079132 application number: ANDA079132 ndc (product): 59746-247 ndc (product): 59746-248 ndc (product): 59746-245 ndc (product): 59746-246

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 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-647	Lamotrigine	Lamotrigine	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-946	Lamotrigine	Lamotrigine	Aidarex Pharmaceuticals LLC	ANDA	Current
42291-366	Lamotrigine	Lamotrigine	AvKARE, Inc.	ANDA	Current
42291-366	Lamotrigine	Lamotrigine	AvKARE, Inc.	ANDA	Current
42291-366	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-367	Lamotrigine	Lamotrigine	AvKARE, Inc.	ANDA	Current
42291-367	Lamotrigine	Lamotrigine	AvKARE, Inc.	ANDA	Current
42291-367	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-368	Lamotrigine	Lamotrigine	AvKARE, Inc.	ANDA	Current
42291-368	Lamotrigine	Lamotrigine	AvKARE, Inc.	ANDA	Current
42291-368	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-369	Lamotrigine	Lamotrigine	AvKARE, Inc.	ANDA	Current
42291-369	Lamotrigine	Lamotrigine	AvKARE, Inc.	ANDA	Current
42291-369	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
50268-461	Lamotrigine	Lamotrigine	AvPAK	ANDA	Current
50268-462	Lamotrigine	Lamotrigine	AvPAK	ANDA	Current
50268-463	Lamotrigine	Lamotrigine	AvPAK	ANDA	Current
50268-464	Lamotrigine	Lamotrigine	AvPAK	ANDA	Current
50436-3995	Lamotrigine	Lamotrigine	Unit Dose Services	ANDA	Current
50436-3996	Lamotrigine	Lamotrigine	Unit Dose Services	ANDA	Current
59746-245	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-245	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-245	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-245	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-246	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-246	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-246	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-246	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-247	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-247	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-247	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-247	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-248	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-248	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-248	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-248	Lamotrigine	Lamotrigine	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
63629-4697	Lamotrigine	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
63629-4697	Lamotrigine	Lamotrigine	Bryant Ranch Prepack	ANDA	Current
68788-7465	Lamotrigine	Lamotrigine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7465	Lamotrigine	Lamotrigine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9526	Lamotrigine	Lamotrigine	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2093	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2503	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2503	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2503	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2503	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-2503	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31415	ORIG	2012-02-14