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Application 210482

Type
ANDA
Sponsor
ANI PHARMS INC

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
43975-289RanolazineRanolazineAmerigen Pharmaceuticals Inc.ANDACurrent
43975-289RanolazineRanolazineANI Pharmaceuticals, Inc.ANDACurrent
43975-289RanolazineRanolazineAmerigen Pharmaceuticals Inc.ANDACurrent
43975-289RanolazineRanolazineANI Pharmaceuticals, Inc.ANDACurrent
43975-290RanolazineRanolazineAmerigen Pharmaceuticals Inc.ANDACurrent
43975-290RanolazineRanolazineANI Pharmaceuticals, Inc.ANDACurrent
43975-290RanolazineRanolazineAmerigen Pharmaceuticals Inc.ANDACurrent
43975-290RanolazineRanolazineANI Pharmaceuticals, Inc.ANDACurrent