Home Applications 103532 Application 103532
Type BLA
Sponsor GENENTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103532 Pulmozyme dornase alfa 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PULMOZYME DORNASE ALFA VIAL 1MG/ML No No
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-100 Pulmozyme dornase alfa Genentech, Inc. BLA Current 50242-100 Pulmozyme dornase alfa Genentech, Inc. BLA Current 50242-100 Pulmozyme dornase alfa Genentech, Inc. BLA Current 50242-100 Pulmozyme dornase alfa Genentech, Inc. BLA Current 50242-100 Pulmozyme dornase alfa Genentech, Inc. BLA Current 50242-100 Pulmozyme dornase alfa Genentech, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 85124 SUPPL 2026-02-24 77474 SUPPL 2024-02-12 77466 SUPPL 2024-02-12 68272 SUPPL 2021-08-03 68241 SUPPL 2021-08-02 18587 SUPPL 2014-12-15 9395 SUPPL 2014-12-15