Application 103532

Type
BLA
Sponsor
GENENTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PULMOZYMEDORNASE ALFAVIAL1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-100Pulmozymedornase alfaGenentech, Inc.BLACurrent
50242-100Pulmozymedornase alfaGenentech, Inc.BLACurrent
50242-100Pulmozymedornase alfaGenentech, Inc.BLACurrent
50242-100Pulmozymedornase alfaGenentech, Inc.BLACurrent
50242-100Pulmozymedornase alfaGenentech, Inc.BLACurrent
50242-100Pulmozymedornase alfaGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85124SUPPL 2026-02-24
77474SUPPL 2024-02-12
77466SUPPL 2024-02-12
68272SUPPL2021-08-03
68241SUPPL2021-08-02
18587SUPPL2014-12-15
9395SUPPL2014-12-15