Application 202498

Type
ANDA
Sponsor
WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL50MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL100MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL200MGNoNo
005LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202498-001LAMOTRIGINELAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04
A202498-002LAMOTRIGINELAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04
A202498-003LAMOTRIGINELAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04
A202498-004LAMOTRIGINELAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04
A202498-005LAMOTRIGINELAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202498-001AB
A202498-002AB
A202498-003AB
A202498-004AB
A202498-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202498-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202498-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202498-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202498-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202498-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202498-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202498-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202498-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202498-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202498-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-005LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-045bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202498-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202498-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202498-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202498-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202498-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202498-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202498-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202498-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202498-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202498-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202498-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202498-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202498-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202498-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202498-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202498-005AB15bbf6a4d5a75…

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 6 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEAmerican Health Packaging35aa48a2-2ce6-4a6e-bf5a-1bc6111d12342026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.60958229-5b5f-49e2-97f4-a8722138f7ce2026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.1d7c2d52-a78e-4508-8853-ba306cdeeaba2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.15d801a0-f0a5-40c1-bc88-d5ba9a02c6962026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.d1691a60-ff0a-4755-b445-1d78309d5af02026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.346f8af3-b850-48e4-bd6e-82ecafca86d22026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.f5761818-4eaf-4335-a77a-9cd703278ded2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.fa679e97-3b3d-4bf2-8de7-da3a89e38b372026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINETorrent Pharmaceuticals Limited22225cc4-028e-43ad-8e1f-dcebdc244ecb2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.6ef17301-6c0b-4941-a84d-12243875d2e22026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.1b5646a9-4724-44b8-8cd0-9c14f5e87f862026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINETorrent Pharmaceuticals Limited3448839b-4933-4ef9-a80a-9e504d2c56962026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.50d46278-636a-470e-afcc-d3c8bd844e462026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINECoupler LLC55f41c7e-03a6-b84c-e063-6294a90a7d822026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.3ed4590d-71e3-4208-b6c0-98330acc7b852026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEREMEDYREPACK INC.de7f61ca-e3c0-4a09-b664-0df2de6a0c302026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINECoupler LLC545fcc0e-1e2b-bdcb-e063-6294a90a4ac72026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEBryant Ranch Prepackb1601109-5c17-4482-9257-1e0be7546e8f2026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.022b0913-f683-4af8-a862-f81b315909b22026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINESun Pharmaceutical Industries, Inc.b829f9b2-f0ac-408a-a6f4-18b72150227d2026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-271LamotrigineLamotrigineWockhardt LimitedANDACurrent
55648-272LamotrigineLamotrigineWockhardt LimitedANDACurrent
55648-273LamotrigineLamotrigineWockhardt LimitedANDACurrent
55648-274LamotrigineLamotrigineWockhardt LimitedANDACurrent
55648-275LamotrigineLamotrigineWockhardt LimitedANDACurrent
64679-271LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-271LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-271LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-272LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-272LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-272LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-273LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-273LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-273LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-274LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-274LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-274LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-275LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-275LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent
64679-275LamotrigineLamotrigineWockhardt USA LLC.ANDACurrent