Home Applications 021426 Application 021426
Type BLA
Sponsor SANDOZ Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021426 Omnitrope somatropin 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMNITROPE SOMATROPIN INJECTABLE;INJECTION 5.8MG/VIAL No No 002 OMNITROPE SOMATROPIN INJECTABLE;INJECTION 1.5MG/VIAL No No 003 OMNITROPE SOMATROPIN INJECTABLE;INJECTION 5MG/1.5ML No No 004 OMNITROPE SOMATROPIN INJECTABLE;INJECTION 10MG/1.5ML 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-3001 Omnitrope Somatropin Sandoz Inc NDA Current 0781-3001 Omnitrope Somatropin Sandoz Inc NDA Current 0781-3001 Omnitrope Somatropin Sandoz Inc BLA Current 0781-3001 Omnitrope Somatropin Sandoz Inc NDA Current 0781-3004 Omnitrope Somatropin Sandoz Inc NDA Current 0781-3004 Omnitrope Somatropin Sandoz Inc NDA Current 0781-3004 Omnitrope Somatropin Sandoz Inc BLA Current 0781-3004 Omnitrope Somatropin Sandoz Inc NDA Current 0781-4004 Omnitrope Somatropin Sandoz Inc NDA Current 0781-4004 Omnitrope Somatropin Sandoz Inc NDA Current 0781-4004 Omnitrope Somatropin Sandoz Inc BLA Current 0781-4004 Omnitrope Somatropin Sandoz Inc NDA Current