FDA.reportPublic FDA data

Application 074769

Type
ANDA
Sponsor
RHODES 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
0904-6560Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6560Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6560Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6560Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
42858-804Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-804Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-804Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-805Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-805Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-805Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
63629-4514morphine sulfatemorphine sulfateBryant Ranch PrepackANDACurrent
63629-4514Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-8505Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-8505Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24048ORIG2015-06-30
22368ORIG1999-03-30
39440ORIG1998-07-02
8443ORIG1998-07-02