FDA.reportPublic FDA data

Application 088072

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUINIDINE SULFATEQUINIDINE SULFATETABLET;ORAL300MGNoNo
002QUINIDINE SULFATEQUINIDINE SULFATETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-1047Quinidine SulfateQuinidine SulfateEon Labs, Inc.ANDACurrent
0185-1047Quinidine SulfateQuinidine SulfateEon Labs, Inc.ANDACurrent
0185-1047Quinidine SulfateQuinidine SulfateEon Labs, Inc.ANDACurrent
0185-4346Quinidine SulfateQuinidine SulfateEon Labs, Inc.ANDACurrent
0185-4346Quinidine SulfateQuinidine SulfateEon Labs, Inc.ANDACurrent
0185-4346Quinidine SulfateQuinidine SulfateEon Labs, Inc.ANDACurrent
42806-512QUINIDINE SULFATEquinidine sulfate tabletEPIC PHARMA, LLCANDACurrent
42806-513QUINIDINE SULFATEquinidine sulfate tabletEPIC PHARMA, LLCANDACurrent