Application 217278

Type: ANDA
Sponsor: ALEMBIC

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
A217278-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-25
A217278-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-25
A217278-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-25
A217278-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217278-001	AB
A217278-002	AB
A217278-003	AB
A217278-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217278-001	LAMOTRIGINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217278-002	LAMOTRIGINE	50MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217278-003	LAMOTRIGINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217278-004	LAMOTRIGINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217278-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217278-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217278-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217278-004	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Limited	03610cdf-7eaa-445c-a441-ff17be5a7c68	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217278 application number: ANDA217278
Lamotrigine	LAMOTRIGINE	Alembic Pharmaceuticals Inc.	df34faa4-829e-413a-a230-cbec604eead9	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217278 application number: ANDA217278