Application 077917

Type
ANDA
Sponsor
LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL10MGNoNo
002PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL20MGNoNo
003PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL40MGNoNo
004PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-485PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-485PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-485PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-485PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-486PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-486PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-486PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-486PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-487PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-487PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-487PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-487PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-488PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-488PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-488PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-488PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
70518-1862PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1863PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
71335-0947PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
71335-0947PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
71335-0947PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
71335-0947PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent