Application 076733

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58177-310Morphine SulfateMorphine SulfateETHEX CorporationANDACurrent
63739-899MORPHINE SULFATEMORPHINE SULFATEMcKesson CorporationANDACurrent
68382-903MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-903MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-903MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-903MORPHINE SULFATEMORPHINE SULFATEZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24058ORIG2015-06-30