FDA.reportPublic FDA data

Application 213603

Type
ANDA
Sponsor
ZHEJIANG YONGTAI

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
69434-042GabapentinGabapentinZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-043GabapentinGabapentinZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-044GabapentinGabapentinZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
71093-161GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-161GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-161GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-161GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-161GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-161GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-162GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-162GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-162GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-162GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-162GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-162GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-163GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-163GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-163GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-163GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-163GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
71093-163GabapentinGabapentinACI Healthcare USA, Inc.ANDACurrent
72189-384GabapentinGabapentinDirect_RxANDACurrent
72189-384GabapentinGabapentinDirect_RxANDACurrent