FDA.reportPublic FDA data

Application 103532

Type
BLA
Sponsor
GENENTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103532Pulmozymedornase alfa351(a)Rx2026-08-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PulmozymeDORNASE ALFAGenentech, Inc.d8c78a7e-ff99-48f3-8952-643ec2ea0f862025-12-17Warnings, Adverse reactionsExact identifier
application number: BLA103532
ndc (product): 50242-100

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

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