FDA.reportPublic FDA data

Application 090401

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET; ORAL5MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET, CHEWABLE;ORAL5MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET, CHEWABLE;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-785LamotrigineLamotrigineRising Pharma Holdings, Inc.ANDACurrent
16571-785LamotrigineLamotrigineRising Pharma Holdings, Inc.ANDACurrent
16571-786LamotrigineLamotrigineRising Pharma Holdings, Inc.ANDACurrent
16571-786LamotrigineLamotrigineRising Pharma Holdings, Inc.ANDACurrent
64980-400LamotrigineLamotrigineRising Pharmaceuticals, Inc.ANDACurrent
64980-400LamotrigineLamotrigineRising Pharmaceuticals, Inc.ANDACurrent
64980-400LamotrigineLamotrigineRising Pharmaceuticals, Inc.ANDACurrent
64980-400LamotrigineLamotrigineRising Pharmaceuticals, Inc.ANDACurrent
64980-401LamotrigineLamotrigineRising Pharmaceuticals, Inc.ANDACurrent
64980-401LamotrigineLamotrigineRising Pharmaceuticals, Inc.ANDACurrent
64980-401LamotrigineLamotrigineRising Pharmaceuticals, Inc.ANDACurrent
64980-401LamotrigineLamotrigineRising Pharmaceuticals, Inc.ANDACurrent
65862-361LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-361LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-361LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-361LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-361LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-361LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-362LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-362LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-362LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-362LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-362LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent
65862-362LamotrigineLamotrigineAurobindo Pharma LimitedANDACurrent