FDA.reportPublic FDA data

Application 076720

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
002MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58177-320Morphine SulfateMorphine SulfateETHEX CorporationANDACurrent
58177-330Morphine SulfateMorphine SulfateETHEX CorporationANDACurrent
63739-726MORPHINE SULFATEMORPHINE SULFATEMcKesson CorporationANDACurrent
68382-904MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-904MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-904MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-904MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-905MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-905MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-905MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-905MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44531ORIG2015-06-30