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 2 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
LamotrigineLAMOTRIGINEBryant Ranch Prepack68a4dac2-5015-40c5-88ca-204098c3b2882026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINECoupler LLC52b8be5c-ef88-dfa7-e063-6394a90a05002026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAurobindo Pharma Limiteda9a4309e-fe43-4a26-a30f-c6577d6503362026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limitedccb33cd0-e5f7-4a50-8b55-ad7c432cdb772026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEUnichem Pharmaceuticals (USA), Inc.4b72ea7a-a0b0-4980-84ad-84f64e2e63682026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals, Inc.16323699-9bf8-43c7-b3aa-5891563778722026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals Inc.09a0d30d-9b8f-4c76-8cdb-8492386b22542026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAvKAREfcdb94a8-33be-6375-98ef-6933999d157f2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEMajor Pharmaceuticals12e0be85-0961-4fe0-b973-83251ecf0f652026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEActavis Pharma, Inc.87beaf22-593d-4170-bb58-332c615ef90d2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LAMOTRIGINELAMOTRIGINESun Pharmaceutical Industries, Inc.83297e2e-9199-4b3d-9f44-a921787758fe2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMOTRIGINE
generic name: LAMOTRIGINE
lamotrigineLAMOTRIGINE EXTENDED-RELEASEREMEDYREPACK INC.65748114-c59c-4ebb-977e-d4aab5764dd32026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lamotrigine
LamotrigineLAMOTRIGINEPar Health USA, LLC003663e5-c0c7-4fc1-a64d-313f2a5b10d22026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINENordic Pharma, Inc.67cf961e-02b9-4a99-944f-43a55df6a5442026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE

Reported adverse events (FAERS/openFDA)#

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