FDA.reportPublic FDA data

Application 206308

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL10MG/5MLNoNo
002MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL100MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-810Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L.P.ANDACurrent
42858-810Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L.P.ANDACurrent
42858-810Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L.P.ANDACurrent
42858-812Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L.P.ANDACurrent
42858-812Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L.P.ANDACurrent
42858-812Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L.P.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76161ORIG 2023-11-03
48828ORIG2017-06-26