FDA.reportPublic FDA data

Application 077855

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL100MGNoNo
002MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58177-340Morphine SulfateMorphine SulfateETHEX CorporationANDACurrent
58177-380Morphine SulfateMorphine SulfateETHEX CorporationANDACurrent
68382-906MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-906MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-906MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-906MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-907MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-907MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-907MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-907MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent