FDA.reportPublic FDA data

Application 205758

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION4MG/MLNoNo
002MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION8MG/MLNoNo
003MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6125Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6125Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6126Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6126Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6127Morphine SulfateMorphine SulfateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6127Morphine SulfateMorphine SulfateHikma Pharmaceuticals USA Inc.ANDACurrent
72572-440Morphine SulfateMorphine SulfateCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32717ORIG2015-05-27