FDA.reportPublic FDA data

Application 077757

Type
ANDA
Sponsor
CARACO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET; ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET; ORAL100MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET; ORAL150MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET; ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEA-S Medication Solutions6139a858-700c-4eb9-9f84-99d280bde3262026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEDr. Reddys Laboratories Inc.54ea1ec3-876b-4d3a-a92b-1a6d70951de02026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINEGolden State Medical Supply, Inc.57f04b9b-06cd-8044-e063-6394a90ae7332026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAmerican Health Packaging35aa48a2-2ce6-4a6e-bf5a-1bc6111d12342026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.50d46278-636a-470e-afcc-d3c8bd844e462026-07-30Boxed 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
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