Application 202498

Type: ANDA
Sponsor: WOCKHARDT LTD

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	300MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202498-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04
A202498-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04
A202498-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04
A202498-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04
A202498-005	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A202498-001	AB
A202498-002	AB
A202498-003	AB
A202498-004	AB
A202498-005	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 6 · 215 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	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-005	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-04	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202498-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202498-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202498-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202498-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202498-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202498-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202498-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202498-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202498-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202498-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202498-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202498-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202498-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202498-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202498-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202498-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202498-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202498-005	AB	1	`03ed91905a0d…`

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 6 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	52273d60-3f27-4846-bf40-014ebcf09417	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Proficient Rx LP	b94ae2e4-e276-40c1-bc25-da980194fc99	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Asclemed USA, Inc.	8ac9dc83-edb2-4ae5-8064-40f113fd3aab	2020-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Dr.Reddy's Laboratories Limited	e1a0da17-d67c-e44f-bd42-33c4009e4cdd	2018-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE
Lamotrigine	LAMOTRIGINE	Amneal Pharmaceuticals of New York LLC	380bddae-5b31-4965-96de-97711d859d11	2016-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lamotrigine generic name: LAMOTRIGINE

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55648-271	Lamotrigine	Lamotrigine	Wockhardt Limited	ANDA	Current
55648-272	Lamotrigine	Lamotrigine	Wockhardt Limited	ANDA	Current
55648-273	Lamotrigine	Lamotrigine	Wockhardt Limited	ANDA	Current
55648-274	Lamotrigine	Lamotrigine	Wockhardt Limited	ANDA	Current
55648-275	Lamotrigine	Lamotrigine	Wockhardt Limited	ANDA	Current
64679-271	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-271	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-271	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-272	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-272	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-272	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-273	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-273	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-273	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-274	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-274	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-274	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-275	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-275	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current
64679-275	Lamotrigine	Lamotrigine	Wockhardt USA LLC.	ANDA	Current