FDA.reportPublic FDA data

Application 078964

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-802RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMmedsource pharmaceuticalsANDACurrent
50090-1424RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMA-S Medication SolutionsANDACurrent
63187-788RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMProficient Rx LPANDACurrent
63187-788RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMProficient Rx LPANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68180-220RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMLupin Pharmaceuticals, Inc.ANDACurrent
68788-6864RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6864RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0656RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.ANDACurrent
70518-0656RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.ANDACurrent
70518-0656RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.ANDACurrent
70518-0656RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMREMEDYREPACK INC.ANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent
71335-0027RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18490ORIG2013-11-19
9205ORIG2013-11-12