Home Applications 021839 Application 021839
Type BLA
Sponsor IPSEN INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021839 Increlex mecasermin 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INCRELEX MECASERMIN RECOMBINANT INJECTABLE;SUBCUTANEOUS 40MG/4ML (10MG/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 · 2 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 15054-1040 Increlex mecasermin Ipsen Biopharmaceuticals, Inc. BLA Current 15054-1040 Increlex mecasermin Ipsen Biopharmaceuticals, Inc. NDA Current 15054-1040 Increlex mecasermin Ipsen Biopharmaceuticals, Inc. NDA Current 15054-1040 Increlex mecasermin Ipsen Biopharmaceuticals, Inc. NDA Current