Application 203733

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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
2019-12-13 00:20 UTC	2019-12	A203733-001	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203733-001	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203733-001	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203733-001	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203733-001	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203733-001	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203733-001	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203733-001	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-11-13	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203733-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203733-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203733-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203733-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203733-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203733-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203733-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203733-001	AB	1	`ea99ee380514…`

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	Actavis Pharma, Inc.	87beaf22-593d-4170-bb58-332c615ef90d	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0228-1638

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-1638	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1638	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1638	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1638	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1638	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current
0228-1638	Lamotrigine	Lamotrigine	Actavis Pharma, Inc.	ANDA	Current