Home Applications 761325 Application 761325
Type BLA
Sponsor SANOFI-AVENTIS U.S. LLC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761325 Merilog insulin aspart-szjj 351(k) Biosimilar Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MERILOG INSULIN ASPART-SZJJ INJECTION;SOLUTION 10ML(100UNITS/ML) No No 002 MERILOG SOLOSTAR INSULIN ASPART-SZJJ INJECTION;SOLUTION 3ML(100UNITS/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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MERILOG INSULIN ASPART-SZJJ Sanofi-Aventis U.S. LLC eee07a52-1102-4d48-9782-26061db175ad 2025-10-07 Warnings, Adverse reactions Exact identifier application number: BLA761325
Documents# Document, Submission type, Date table Document Submission type Date 82309 ORIG 2025-05-27 81259 ORIG 2025-02-14 81255 ORIG 2025-02-14