Application 211707

Type
ANDA
Sponsor
SUN PHARM

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
63304-017RanolazineRanolazineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-017RanolazineRanolazineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-017RanolazineRanolazineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-017RanolazineRanolazineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-018RanolazineRanolazineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-018RanolazineRanolazineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-018RanolazineRanolazineSun Pharmaceutical Industries, Inc.ANDACurrent
63304-018RanolazineRanolazineSun Pharmaceutical Industries, Inc.ANDACurrent