FDA.reportPublic FDA data

Application 211059

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDE; SIMETHICONELOPERAMIDE HYDROCHLORIDE;SIMETHICONEUNKNOWNUNKNOWNNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9606Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeWALGREEN CO.ANDACurrent
58602-815Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
58602-815Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
58602-815Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
58602-868Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
58602-868Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
58602-868Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
58602-869Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
58602-869Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
58602-869Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeAurohealth LLCANDACurrent
80136-384Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and SimethiconeNORTHEAST PHARMAANDACurrent