Home Applications 019774 Application 019774
Type BLA
Sponsor FERRING Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 019774 Zomacton somatropin 351(a) Disc 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BIO-TROPIN SOMATROPIN INJECTABLE;INJECTION 4.8MG/VIAL No No 002 ZOMACTON SOMATROPIN INJECTABLE;INJECTION 5MG/VIAL No No 003 ZOMACTON SOMATROPIN INJECTABLE;INJECTION 10MG/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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55566-1801 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1801 ZOMACTON somatropin Ferring Pharmaceuticals Inc. NDA Current 55566-1801 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1801 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1801 ZOMACTON somatropin Ferring Pharmaceuticals Inc. NDA Current 55566-1801 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1901 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1901 ZOMACTON somatropin Ferring Pharmaceuticals Inc. NDA Current 55566-1901 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1901 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1901 ZOMACTON somatropin Ferring Pharmaceuticals Inc. NDA Current 55566-1901 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1902 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1902 ZOMACTON somatropin Ferring Pharmaceuticals Inc. NDA Current 55566-1902 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1902 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current 55566-1902 ZOMACTON somatropin Ferring Pharmaceuticals Inc. NDA Current 55566-1902 ZOMACTON somatropin Ferring Pharmaceuticals Inc. BLA Current