FDA.reportPublic FDA data

Application 200403

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEINJECTABLE;INJECTION1MG/MLNoNo
002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEINJECTABLE;INJECTION2MG/MLNoNo
003HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEINJECTABLE;INJECTION4MG/MLNoNo
004HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEINJECTABLE;INJECTION0.5MG/0.5MLNoNo
005HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEINJECTABLE;INJECTION0.25MG/0.5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1304Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1312Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2540Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2540Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2540Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2540Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-2552Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3356Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3356Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3356Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3356Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-3365Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-4264Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-4264Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84637SUPPL 2026-01-05
84617SUPPL 2025-12-31
77069SUPPL 2023-12-19
76942SUPPL 2023-12-18
60448SUPPL2019-10-09
60281SUPPL2019-10-07
46389SUPPL2016-12-21
46329SUPPL2016-12-20
9822SUPPL2015-07-20
40022SUPPL2015-07-17
44821ORIG2012-06-05
22831ORIG2012-06-05
9820ORIG2011-12-05
40021ORIG2011-12-02
9821ORIG2011-03-02