FDA.reportPublic FDA data

Application 090595

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-8020Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8020Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8020Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8020Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8020Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8020Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8021Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8021Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8021Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8021Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8021Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
0378-8021Fluvastatin SodiumfluvastatinMylan Pharmaceuticals Inc.ANDACurrent
68151-1326Fluvastatin SodiumfluvastatinCarilion Materials ManagementANDACurrent
68151-1334Fluvastatin SodiumfluvastatinCarilion Materials ManagementANDACurrent