Home Applications 020898 Application 020898
Type BLA
Sponsor GENZYME Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 020898 Thyrogen thyrotropin alfa 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 THYROGEN THYROTROPIN ALFA INJECTABLE;INJECTION 1.1MG/VIAL 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58468-0030 Thyrogen THYROTROPIN ALFA Genzyme Corporation BLA Current 58468-0030 Thyrogen THYROTROPIN ALFA Genzyme Corporation NDA Current 58468-0030 Thyrogen THYROTROPIN ALFA Genzyme Corporation BLA Current 58468-1849 Thyrogen THYROTROPIN ALFA Genzyme Corporation NDA Current