FDA.reportPublic FDA data

Application 201046

Type
ANDA
Sponsor
LUPIN LTD

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
60687-460RanolazineRanolazineAmerican Health PackagingANDACurrent
68180-354RANOLAZINERANOLAZINELupin Pharmaceuticals, Inc.ANDACurrent
68180-354RANOLAZINERANOLAZINELupin Pharmaceuticals, Inc.ANDACurrent
68180-354RANOLAZINERANOLAZINELupin Pharmaceuticals, Inc.ANDACurrent
68180-354RANOLAZINERANOLAZINELupin Pharmaceuticals, Inc.ANDACurrent
68180-355RANOLAZINERANOLAZINELupin Pharmaceuticals, Inc.ANDACurrent
68180-355RANOLAZINERANOLAZINELupin Pharmaceuticals, Inc.ANDACurrent
68180-355RANOLAZINERANOLAZINELupin Pharmaceuticals, Inc.ANDACurrent
68180-355RANOLAZINERANOLAZINELupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32080ORIG2013-07-31