FDA.reportPublic FDA data

Application 216131

Type
ANDA
Sponsor
HAINAN POLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 12.5MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14335-171DobutamineDobutamineHainan Poly Pharm. Co., Ltd.ANDACurrent
14335-172DobutamineDobutamineHainan Poly Pharm. Co., Ltd.ANDACurrent