FDA.reportPublic FDA data

Application 078134

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9964LamotrigineLamotrigineHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9964LamotrigineLamotrigineWest-ward Pharmaceutical CorpANDACurrent
0143-9965LamotrigineLamotrigineHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9965LamotrigineLamotrigineWest-ward Pharmaceutical CorpANDACurrent
0143-9966LamotrigineLamotrigineHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9966LamotrigineLamotrigineWest-ward Pharmaceutical CorpANDACurrent
0143-9967LamotrigineLamotrigineHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9967LamotrigineLamotrigineWest-ward Pharmaceutical CorpANDACurrent
59115-065LamotrigineLamotrigineHikma PharmaceuticalANDACurrent
59115-065LamotrigineLamotrigineHikma PharmaceuticalANDACurrent
59115-066LamotrigineLamotrigineHikma PharmaceuticalANDACurrent
59115-066LamotrigineLamotrigineHikma PharmaceuticalANDACurrent
59115-067LamotrigineLamotrigineHikma PharmaceuticalANDACurrent
59115-067LamotrigineLamotrigineHikma PharmaceuticalANDACurrent
59115-068LamotrigineLamotrigineHikma PharmaceuticalANDACurrent
59115-068LamotrigineLamotrigineHikma PharmaceuticalANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9122ORIG2012-02-14