FDA.reportPublic FDA data

Application 079011

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUVASTATIN SODIUMFLUVASTATIN SODIUMTABLET, EXTENDED RELEASE;ORALEQ 80MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7446Fluvastatin SodiumFluvastatin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7446Fluvastatin SodiumFluvastatin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7446Fluvastatin SodiumFluvastatin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7446Fluvastatin SodiumFluvastatin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7446Fluvastatin SodiumFluvastatin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent