Application 213271

Type: ANDA
Sponsor: AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	25MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	50MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;ORAL	100MG	No	No
004	LAMOTRIGINE	LAMOTRIGINE	TABLET, ORALLY DISINTEGRATING;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
A213271-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19
A213271-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19
A213271-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19
A213271-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A213271-001	AB
A213271-002	AB
A213271-003	AB
A213271-004	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 4 · 140 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	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213271-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2021-01-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A213271-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213271-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213271-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213271-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213271-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213271-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213271-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213271-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213271-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213271-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213271-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213271-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213271-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Ajanta Pharma USA Inc.	9dfb5f87-0150-4c26-a89f-34f1ab389500	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213271 application number: ANDA213271 ndc (product): 27241-183 ndc (product): 27241-185 ndc (product): 27241-184 ndc (product): 27241-186

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-183	Lamotrigine	Lamotrigine	Ajanta Pharma USA Inc.	ANDA	Current
27241-183	Lamotrigine	Lamotrigine	Ajanta Pharma Limited	ANDA	Current
27241-183	Lamotrigine	Lamotrigine	Ajanta Pharma Limited	ANDA	Current
27241-184	Lamotrigine	Lamotrigine	Ajanta Pharma USA Inc.	ANDA	Current
27241-184	Lamotrigine	Lamotrigine	Ajanta Pharma Limited	ANDA	Current
27241-184	Lamotrigine	Lamotrigine	Ajanta Pharma Limited	ANDA	Current
27241-185	Lamotrigine	Lamotrigine	Ajanta Pharma USA Inc.	ANDA	Current
27241-185	Lamotrigine	Lamotrigine	Ajanta Pharma Limited	ANDA	Current
27241-185	Lamotrigine	Lamotrigine	Ajanta Pharma Limited	ANDA	Current
27241-186	Lamotrigine	Lamotrigine	Ajanta Pharma USA Inc.	ANDA	Current
27241-186	Lamotrigine	Lamotrigine	Ajanta Pharma Limited	ANDA	Current
27241-186	Lamotrigine	Lamotrigine	Ajanta Pharma Limited	ANDA	Current