FDA.reportPublic FDA data

Application 202515

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION2MG/MLYesYes
002MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION4MG/MLYesYes
003MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION8MG/MLYesYes
004MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION10MG/MLYesYes
005MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION15MG/MLYesNo
006MORPHINE SULFATEMORPHINE SULFATEINJECTABLE;INJECTION50MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1890Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1891Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1892Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1892Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1892Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1892Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1892Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1892Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent
0409-1893Morphine SulfateMORPHINE SULFATEHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84678SUPPL 2026-01-06
84574SUPPL 2025-12-29
77054SUPPL 2023-12-19
76965SUPPL 2023-12-18
70914SUPPL2022-05-03
70883SUPPL2022-05-02
67311SUPPL2021-04-30
67262SUPPL2021-04-30
64893SUPPL2020-10-19
64891SUPPL2020-10-13
60303SUPPL2019-10-08
60279SUPPL2019-10-07
46428SUPPL2016-12-21
46303SUPPL2016-12-20
44860ORIG2012-06-26
43406ORIG2012-06-26
32270ORIG2011-11-28
19357ORIG2011-11-14