FDA.reportPublic FDA data

Application 076483

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSINOPRIL SODIUMFOSINOPRIL SODIUMTABLET;ORAL10MGNoNo
002FOSINOPRIL SODIUMFOSINOPRIL SODIUMTABLET;ORAL20MGNoNo
003FOSINOPRIL SODIUMFOSINOPRIL SODIUMTABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0041Fosinopril SodiumFosinopril SodiumEon Labs, Inc.ANDACurrent
0185-0042Fosinopril SodiumFosinopril SodiumEon Labs, Inc.ANDACurrent
0185-0047Fosinopril SodiumFosinopril SodiumEon Labs, Inc.ANDACurrent
50090-0890Fosinopril SodiumFosinopril SodiumA-S Medication SolutionsANDACurrent
67544-306Fosinopril SodiumFosinopril SodiumAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
67544-322Fosinopril SodiumFosinopril SodiumAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
68258-6106Fosinopril SodiumFosinopril SodiumDispensing Solutions, Inc.ANDACurrent