Application 213949

Type: ANDA
Sponsor: YILING

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 1.

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
A213949-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08
A213949-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08
A213949-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08
A213949-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08
A213949-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08
A213949-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213949-001	AB
A213949-002	AB
A213949-003	AB
A213949-004	AB
A213949-005	AB
A213949-006	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 5 · 198 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	A213949-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213949-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213949-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213949-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213949-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213949-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-12-08	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 198 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	A213949-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213949-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213949-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213949-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213949-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213949-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213949-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213949-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213949-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213949-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213949-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213949-004	AB	1	`2680178bc6a6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	REMEDYREPACK INC.	65748114-c59c-4ebb-977e-d4aab5764dd3	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213949 application number: ANDA213949
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	Camber Pharmaceuticals Inc	e45bd69f-3580-ff15-e053-2a95a90a4615	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213949 application number: ANDA213949 ndc (product): 31722-241 ndc (product): 31722-243 ndc (product): 31722-240 ndc (product): 31722-244 ndc (product): 31722-242 ndc (product): 31722-245
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	Yiling Pharmaceutical, Inc.	f7de11a5-5357-4753-b1ac-b15123b50028	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213949 application number: ANDA213949 ndc (product): 69117-0048 ndc (product): 69117-0044 ndc (product): 69117-0045 ndc (product): 69117-0049 ndc (product): 69117-0047 ndc (product): 69117-0046
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	REMEDYREPACK INC.	70ae07a2-2f5c-4b3f-b8c7-1ac8b83c0593	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213949 application number: ANDA213949
Lamotrigine ER	LAMOTRIGINE ER	Direct_rx	1b42a7cf-86d8-e506-e063-6394a90a3c9b	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213949 application number: ANDA213949
lamotrigine	LAMOTRIGINE EXTENDED-RELEASE	Proficient Rx LP	39efe933-bfed-4a6a-b270-0883871c5186	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213949 application number: ANDA213949

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-240	lamotrigine	lamotrigine extended-release	Camber Pharmaceuticals Inc	ANDA	Current
31722-241	lamotrigine	lamotrigine extended-release	Camber Pharmaceuticals Inc	ANDA	Current
31722-242	lamotrigine	lamotrigine extended-release	Camber Pharmaceuticals Inc	ANDA	Current
31722-243	lamotrigine	lamotrigine extended-release	Camber Pharmaceuticals Inc	ANDA	Current
31722-244	lamotrigine	lamotrigine extended-release	Camber Pharmaceuticals Inc	ANDA	Current
31722-245	lamotrigine	lamotrigine extended-release	Camber Pharmaceuticals Inc	ANDA	Current
69117-0044	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0044	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0045	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0045	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0046	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0046	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0047	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0047	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0048	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0048	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0049	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0049	lamotrigine	lamotrigine extended-release	Yiling Pharmaceutical, Inc.	ANDA	Current