FDA.reportPublic FDA data

Application 103293

Type
BLA
Sponsor
CHIRON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROLEUKINALDESLEUKINVIAL22MIU/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65483-116ProleukinaldesleukinPrometheus Laboratories Inc.BLACurrent
65483-116ProleukinaldesleukinPrometheus Laboratories Inc.BLACurrent
76310-022ProleukinaldesleukinClinigen Group PLCBLACurrent
76310-022ProleukinaldesleukinClinigen Group PLCBLACurrent
76310-022ProleukinaldesleukinClinigen Group PLCBLACurrent
76310-022ProleukinaldesleukinClinigen LimitedBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75648SUPPL 2023-10-03
75636SUPPL 2023-10-02
58782SUPPL2019-05-20
31578SUPPL2012-08-01
39645SUPPL2012-07-30
9381SUPPL2012-01-05
9380SUPPL2011-08-02
43268SUPPL2004-03-26
9379SUPPL2004-03-26