Home Applications 761432 Application 761432
Type BLA
Sponsor MERCK SHARP DOHME Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761432 Enflonsia clesrovimab-cfor 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENFLONSIA CLESROVIMAB-CFOR INJECTION;SOLUTION 105MG/0.7ML 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 ENFLONSIA CLESROVIMAB Merck Sharp & Dohme LLC c9004a92-40e8-4cdb-b22d-d07929f8fc3b 2025-06-20 Warnings, Adverse reactions Exact identifier application number: BLA761432
Documents# Document, Submission type, Date table Document Submission type Date 82880 ORIG 2025-07-16 82520 ORIG 2025-06-10 82516 ORIG 2025-06-10