FDA.reportPublic FDA data

Application 078407

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUVASTATIN SODIUMFLUVASTATIN SODIUMCAPSULE;ORALEQ 20MG BASENoNo
002FLUVASTATIN SODIUMFLUVASTATIN SODIUMCAPSULE;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7442FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7442FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7442FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7442FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7442FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7443FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7443FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7443FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7443FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7443FluvastatinFluvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
63629-8737FluvastatinFluvastatinBryant Ranch PrepackANDACurrent
63629-8737FluvastatinFluvastatinBryant Ranch PrepackANDACurrent
63629-8812FluvastatinFluvastatinBryant Ranch PrepackANDACurrent
63629-8812FluvastatinFluvastatinBryant Ranch PrepackANDACurrent