FDA.reportPublic FDA data

Application 212781

Type
ANDA
Sponsor
SUNGEN PHARMA

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
42291-773RanolazineRANOLAZINEAvKAREANDACurrent
42291-773RanolazineRANOLAZINEAvKAREANDACurrent
42291-774RanolazineRANOLAZINEAvKAREANDACurrent
42291-774RanolazineRANOLAZINEAvKAREANDACurrent
70625-206RanolazineRANOLAZINESunGen Pharma LLCANDACurrent
70625-206RanolazineRANOLAZINEPraxgen Pharmaceuticals LLCANDACurrent
70625-207RanolazineRANOLAZINESunGen Pharma LLCANDACurrent
70625-207RanolazineRANOLAZINEPraxgen Pharmaceuticals LLCANDACurrent
71610-518RanolazineRANOLAZINEAphena Pharma Solutions - Tennessee, LLCANDACurrent