FDA.reportPublic FDA data

Application 019916

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION1MG/MLYesYes
002MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION5MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2029Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-2029Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-6028Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
70518-1107Morphine SulfateMORPHINE SULFATEREMEDYREPACK INC.NDACurrent
70518-1107Morphine SulfateMORPHINE SULFATEREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60473SUPPL2019-10-09
60275SUPPL2019-10-07
46388SUPPL2016-12-21
46387SUPPL2016-12-21
46245SUPPL2016-12-20
46244SUPPL2016-12-20
19844SUPPL2006-11-06
11850SUPPL2006-11-06