Application 201374

Type: ANDA
Sponsor: ANCHEN 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 44.

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
A201374-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26
A201374-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201374-001	AB
A201374-002	AB
A201374-003	AB
A201374-004	AB
A201374-005	AB
A201374-006	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 7 of 7 · 264 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
2022-10-28 04:53 UTC	2022-10	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201374-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201374-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201374-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201374-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201374-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201374-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-12-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 186 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A201374-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201374-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201374-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201374-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201374-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201374-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201374-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201374-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201374-006	AB	1	`31067a03dcf5…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201374-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201374-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201374-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201374-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201374-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201374-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201374-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201374-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201374-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201374-004	AB	1	`5d02ea3f76ae…`

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 Extended-Release	LAMOTRIGINE	Par Health USA, LLC	d5ec4d58-c669-4ab4-ba62-b71007536854	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201374 application number: ANDA201374

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22852	ORIG	2013-02-26