Home Applications 019640 Application 019640
Type BLA
Sponsor LILLY Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 019640 Humatrope somatropin 351(a) Disc 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HUMATROPE SOMATROPIN INJECTABLE;INJECTION 2MG/VIAL No No 004 HUMATROPE SOMATROPIN INJECTABLE;INJECTION 5MG/VIAL No No 005 HUMATROPE SOMATROPIN INJECTABLE;INJECTION 6MG/VIAL No No 006 HUMATROPE SOMATROPIN INJECTABLE;INJECTION 12MG/VIAL No No 007 HUMATROPE SOMATROPIN INJECTABLE;INJECTION 24MG/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 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-7335 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-7335 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-7335 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-7335 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-7335 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-7335 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8147 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8147 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8147 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8147 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8147 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8147 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8147 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8148 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8148 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8148 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8148 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8148 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8148 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8148 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8149 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8149 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8149 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8149 HUMATROPE Somatropin Eli Lilly and Company BLA Current 0002-8149 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8149 HUMATROPE Somatropin Eli Lilly and Company NDA Current 0002-8149 HUMATROPE Somatropin Eli Lilly and Company BLA Current