FDA.reportPublic FDA data

Application 215001

Type
ANDA
Sponsor
EDENBRIDGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECAPSULE;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42799-605Loperamide HydrochlorideLoperamide HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
50090-6208Loperamide HydrochlorideLoperamide HydrochlorideA-S Medication SolutionsANDACurrent
70518-3413Loperamide HydrochlorideLoperamide HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-2111Loperamide HydrochlorideLoperamide HydrochlorideBryant Ranch PrepackANDACurrent
71610-648Loperamide HydrochlorideLoperamide HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent