Application 207763

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	25MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	50MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
004	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No
005	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	250MG	No	No
006	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207763-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A207763-001	AB
A207763-002	AB
A207763-003	AB
A207763-004	AB
A207763-005	AB
A207763-006	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 6 · 228 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
2026-08-18 06:07:40	2026-07	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 228 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207763-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207763-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207763-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207763-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207763-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207763-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207763-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207763-004	AB	1	`03ed91905a0d…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	fa679e97-3b3d-4bf2-8de7-da3a89e38b37	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207763 application number: ANDA207763
Lamotrigine	LAMOTRIGINE	Zydus Pharmaceuticals USA Inc.	eb436371-d188-4803-a864-07b90c357e57	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207763 application number: ANDA207763 ndc (product): 68382-981 ndc (product): 68382-983 ndc (product): 68382-982 ndc (product): 68382-980 ndc (product): 68382-979 ndc (product): 68382-984
Lamotrigine ER	LAMOTRIGINE ER	Direct_Rx	faccacb7-65f1-cb00-e053-6394a90a9fcb	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207763 application number: ANDA207763
Lamotrigine	LAMOTIRIGINE	Zydus Lifesciences Limited	ecb7a528-699f-4e51-9887-dee60456da2f	2024-11-30		Exact identifier application applno (ANDA): 207763 application number: ANDA207763 ndc (product): 70771-1518 ndc (product): 70771-1517 ndc (product): 70771-1516 ndc (product): 70771-1514 ndc (product): 70771-1515 ndc (product): 70771-1519

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-979	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-979	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-979	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-979	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-980	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-980	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-980	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-980	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-981	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-981	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-981	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-981	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-982	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-982	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-982	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-982	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-983	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-983	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-983	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-983	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-984	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-984	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-984	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-984	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1514	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1514	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1515	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1515	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1516	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1516	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1517	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1517	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1518	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1518	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1519	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1519	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current