Application 077661

Type
ANDA
Sponsor
RUBICON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004GABAPENTINGABAPENTINTABLET;ORAL600MGNoNo
005GABAPENTINGABAPENTINTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-2551GabapentinGabapentinApotex Corp.ANDACurrent
60505-2551GabapentinGabapentinApotex Corp.ANDACurrent
60505-2551GabapentinGabapentinApotex Corp.ANDACurrent
60505-2552GabapentinGabapentinApotex Corp.ANDACurrent
60505-2552GabapentinGabapentinApotex Corp.ANDACurrent
60505-2552GabapentinGabapentinApotex Corp.ANDACurrent
60505-2552GabapentinGabapentinApotex Corp.ANDACurrent
60505-2552GabapentinGabapentinApotex Corp.ANDACurrent
68071-3244GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
72888-131GabapentingabapentinAdvagen Pharma LtdANDACurrent
72888-132GabapentingabapentinAdvagen Pharma LtdANDACurrent