FDA.reportPublic FDA data

Application 215579

Type
ANDA
Sponsor
BIONPHARMA INC

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
68071-2700Loperamide HydrochlorideLoperamide HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2700Loperamide HydrochlorideLoperamide HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2863Loperamide Hydrochlorideloperamide hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
69452-271Loperamide Hydrochlorideloperamide hydrochlorideBionpharma Inc.ANDACurrent
69452-271Loperamide Hydrochlorideloperamide hydrochlorideBionpharma Inc.ANDACurrent
70518-3400Loperamide Hydrochlorideloperamide hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3400Loperamide Hydrochlorideloperamide hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3400Loperamide Hydrochlorideloperamide hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-2061Loperamide Hydrochlorideloperamide hydrochlorideBryant Ranch PrepackANDACurrent