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 6 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEProficient Rx LP52273d60-3f27-4846-bf40-014ebcf094172022-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEProficient Rx LPb94ae2e4-e276-40c1-bc25-da980194fc992022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAsclemed USA, Inc.8ac9dc83-edb2-4ae5-8064-40f113fd3aab2020-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limitede1a0da17-d67c-e44f-bd42-33c4009e4cdd2018-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamotrigine
generic name: LAMOTRIGINE
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC380bddae-5b31-4965-96de-97711d859d112016-02-02Boxed 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.