FDA.reportPublic FDA data

Application 206548

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58602-701Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent
58602-701Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent
58602-701Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent
58602-701Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent
58602-701Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent
58602-701Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent
58602-701Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent
58602-827Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent
58602-870Loperamide HydrochlorideLoperamide HydrochlorideAurohealth LLCANDACurrent