FDA.reportPublic FDA data

Application 075477

Type
ANDA
Sponsor
CSPC OUYI

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
50090-5322GabapentinGabapentinA-S Medication SolutionsANDACurrent
51224-019GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-019GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-019GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-119GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-119GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-119GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-219GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-219GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-219GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
69367-343GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-344GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-345GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
70518-3140GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
80425-0149NeurotinGabapentin 300mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0149GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0149GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0196GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0199GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent