FDA.reportPublic FDA data

Application 207057

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET;ORAL600MGNoNo
002GABAPENTINGABAPENTINTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4445GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-4445GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-5331GabapentinGabapentinA-S Medication SolutionsANDACurrent
51224-021GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-021GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-021GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-021GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-121GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-121GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-121GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
51224-121GabapentinGabapentinTAGI Pharma, Inc.ANDACurrent
69367-346GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-347GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
70518-2960GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2960GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2960GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2960GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2960GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
71335-1287GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1287GabapentinGabapentinBryant Ranch PrepackANDACurrent
71717-102GABAPENTINGABAPENTINMegalith Pharmaceuticals IncANDACurrent
71717-103GABAPENTINGABAPENTINMegalith Pharmaceuticals IncANDACurrent
80425-0201GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0204GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent