Home Applications 761079 Application 761079
Type BLA
Sponsor BIOMARIN PHARM Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761079 Palynziq pegvaliase-pqpz 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PALYNZIQ PEGVALIASE-PQPZ INJECTABLE;INJECTION 2.5MG/O.5ML No No 002 PALYNZIQ PEGVALIASE-PQPZ INJECTABLE;INJECTION 10MG/0.5ML No No 003 PALYNZIQ PEGVALIASE-PQPZ INJECTABLE;INJECTION 20MG/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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68135-058 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-058 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-058 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-058 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-058 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-673 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-673 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-673 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-673 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-673 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-756 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-756 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-756 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-756 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current 68135-756 Palynziq pegvaliase-pqpz BioMarin Pharmaceutical Inc. BLA Current