FDA.reportPublic FDA data

Application 208931

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINELORATADINESYRUP;ORAL1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30142-062LoratadineLoratadine OralKROGER COMPANYANDACurrent
30142-062LoratadineLoratadine OralKROGER COMPANYANDACurrent
58602-423LoratadineLoratadine OralAurohealth LLCANDACurrent
58602-423LoratadineLoratadine OralAurohealth LLCANDACurrent
58602-423LoratadineLoratadine OralAurohealth LLCANDACurrent
58602-423LoratadineLoratadine OralAurohealth LLCANDACurrent
68001-449LoratadineLoratadine OralBluePoint LaboratoriesANDACurrent