FDA.reportPublic FDA data

Application 078150

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-3991GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-3993GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-3994GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-9992GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-9993GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
0143-9994GabapentinGabapentinWest-ward Pharmaceutical CorpANDACurrent
59115-073GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-073GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-074GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-074GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-075GabapentinGabapentinHikma PharmaceuticalANDACurrent
59115-075GabapentinGabapentinHikma PharmaceuticalANDACurrent
66336-439GabapentinGabapentinDispensing Solutions, Inc.ANDACurrent
66336-567GabapentinGabapentinDispensing Solutions, Inc.ANDACurrent