Home Applications 021629 Application 021629
Type BLA
Sponsor SANOFI AVENTIS US Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021629 Apidra insulin glulisine 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 APIDRA INSULIN GLULISINE RECOMBINANT INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 1000 UNITS/10ML (100 UNITS/ML) No No 002 APIDRA INSULIN GLULISINE RECOMBINANT INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 300 UNITS/3ML (100 UNITS/ML) No No 003 APIDRA SOLOSTAR INSULIN GLULISINE RECOMBINANT INJECTABLE;SUBCUTANEOUS 300 UNITS/3ML 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.
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NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0088-2500 Apidra insulin glulisine sanofi-aventis U.S. LLC BLA Current 0088-2500 Apidra insulin glulisine sanofi-aventis U.S. LLC BLA Current 0088-2500 Apidra insulin glulisine sanofi-aventis U.S. LLC NDA Current 0088-2500 Apidra insulin glulisine sanofi-aventis U.S. LLC NDA Current 0088-2500 Apidra insulin glulisine sanofi-aventis U.S. LLC BLA Current 0088-2500 Apidra insulin glulisine sanofi-aventis U.S. LLC BLA Current 0088-2500 Apidra insulin glulisine Sanofi-Aventis U.S. LLC NDA Current 0088-2502 Apidra SoloStar insulin glulisine sanofi-aventis U.S. LLC BLA Current 0088-2502 Apidra SoloStar insulin glulisine sanofi-aventis U.S. LLC BLA Current 0088-2502 Apidra SoloStar insulin glulisine sanofi-aventis U.S. LLC NDA Current 0088-2502 Apidra SoloStar insulin glulisine sanofi-aventis U.S. LLC NDA Current 0088-2502 Apidra SoloStar insulin glulisine sanofi-aventis U.S. LLC BLA Current 0088-2502 Apidra SoloStar insulin glulisine sanofi-aventis U.S. LLC BLA Current 0088-2502 Apidra SoloStar insulin glulisine Sanofi-Aventis U.S. LLC NDA Current