Application 203370

Type: ANDA
Sponsor: TORRENT

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203370-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23
A203370-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203370-001	AB
A203370-002	AB
A203370-003	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 · 172 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
2026-09-14 22:38:34	2026-08	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203370-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-12-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 143 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203370-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203370-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203370-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A203370-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203370-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203370-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203370-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203370-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203370-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203370-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203370-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203370-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203370-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203370-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203370-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203370-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203370-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203370-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203370-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203370-004	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203370-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203370-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203370-003	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	de7f61ca-e3c0-4a09-b664-0df2de6a0c30	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370 ndc (product): 70518-1153
Lamotrigine	LAMOTRIGINE	Torrent Pharmaceuticals Limited	52df02a7-83da-4b20-9951-69790237dc24	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370 ndc (product): 13668-340 ndc (product): 13668-339 ndc (product): 13668-342 ndc (product): 13668-341
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	ffa46cb2-16e7-45f3-9940-5cb88d0cda9d	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203370 application number: ANDA203370

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-339	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-340	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-341	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-342	Lamotrigine	Lamotrigine	Torrent Pharmaceuticals Limited	ANDA	Current
70518-1153	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current
70518-1153	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current