Home Applications 208673 Application 208673
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 208673 Soliqua 100/33 insulin glargine and lixisenatide 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SOLIQUA 100/33 INSULIN GLARGINE; LIXISENATIDE SOLUTION;SUBCUTANEOUS 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/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.
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NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide Sanofi-Aventis U.S. LLC NDA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide Sanofi-Aventis U.S. LLC BLA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide Sanofi-Aventis U.S. LLC NDA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide Sanofi-Aventis U.S. LLC BLA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide Sanofi-Aventis U.S. LLC NDA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide Sanofi-Aventis U.S. LLC NDA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide sanofi-aventis U.S. LLC BLA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide Sanofi-Aventis U.S. LLC NDA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide sanofi-aventis U.S. LLC BLA Current 0024-5761 Soliqua 100/33 insulin glargine and lixisenatide Sanofi-Aventis U.S. LLC BLA Current