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Application 210188

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70771-1499RanolazineRanolazineZydus Lifesciences LimitedANDACurrent
70771-1499RanolazineRanolazineCadila Healthcare LimitedANDACurrent
70771-1500RanolazineRanolazineZydus Lifesciences LimitedANDACurrent
70771-1500RanolazineRanolazineCadila Healthcare LimitedANDACurrent
72578-064RanolazineRanolazineViona Pharmaceuticals IncANDACurrent
72578-064RanolazineRanolazineViona Pharmaceuticals IncANDACurrent
72578-064RanolazineRanolazineViona Pharmaceuticals IncANDACurrent
72578-065RanolazineRanolazineViona Pharmaceuticals IncANDACurrent
72578-065RanolazineRanolazineViona Pharmaceuticals IncANDACurrent
72578-065RanolazineRanolazineViona Pharmaceuticals IncANDACurrent