RxBNNovolog
insulin aspart
2 reference · 2 interchangeable · 3 biosimilar-only
Reference Product
Novolog
insulin aspart
351(a) Reference Product (Approval Date 7-Jun-2000)
ApplicantNovo Nordisk Inc.
BLA020986
RouteIntravenous, Subcutaneous
Presentation
Multi-Dose Vial
Novolog
insulin aspart
351(a) Reference Product (Approval Date 7-Jun-2000)
ApplicantNovo Nordisk Inc.
BLA020986
·RouteIntravenous, Subcutaneous
Presentation
Multi-Dose Vial
Novolog
insulin aspart
351(a) Reference Product (Approval Date 7-Jun-2000)
ApplicantNovo Nordisk Inc.
BLA020986
RouteSubcutaneous
Presentation
AutoinjectorMulti-Dose Cartridge
Novolog
insulin aspart
351(a) Reference Product (Approval Date 7-Jun-2000)
ApplicantNovo Nordisk Inc.
BLA020986
·RouteSubcutaneous
Presentation
AutoinjectorMulti-Dose Cartridge
Interchangeable Biosimilars
Kirsty
insulin aspart-xjhz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 15-Jul-2025)
ApplicantBiocon Biologics Inc.
BLA761188
RouteIntravenous, Subcutaneous
Presentation
Multi-Dose Vial
Kirsty
insulin aspart-xjhz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 15-Jul-2025)
ApplicantBiocon Biologics Inc.
BLA761188
·RouteIntravenous, Subcutaneous
Presentation
Multi-Dose Vial
Kirsty
insulin aspart-xjhz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 15-Jul-2025)
ApplicantBiocon Biologics Inc.
BLA761188
RouteSubcutaneous
Presentation
Autoinjector
Kirsty
insulin aspart-xjhz
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 15-Jul-2025)
ApplicantBiocon Biologics Inc.
BLA761188
·RouteSubcutaneous
Presentation
Autoinjector
Biosimilars (not interchangeable)
Garzulys
insulin aspart-fsan
351(k) Biosimilar (Approval Date 24-Jul-2026)
ApplicantEmerge Bioscience Pte. Ltd.
BLA761497
RouteSubcutaneous
Presentation
Autoinjector
Garzulys
insulin aspart-fsan
351(k) Biosimilar (Approval Date 24-Jul-2026)
ApplicantEmerge Bioscience Pte. Ltd.
BLA761497
·RouteSubcutaneous
Presentation
Autoinjector
Garzulys
insulin aspart-fsan
351(k) Biosimilar (Approval Date 24-Jul-2026)
ApplicantEmerge Bioscience Pte. Ltd.
BLA761497
RouteIntravenous, Subcutaneous
Presentation
Multi-Dose Vial
Garzulys
insulin aspart-fsan
351(k) Biosimilar (Approval Date 24-Jul-2026)
ApplicantEmerge Bioscience Pte. Ltd.
BLA761497
·RouteIntravenous, Subcutaneous
Presentation
Multi-Dose Vial
Merilog
insulin aspart-szjj
351(k) Biosimilar (Approval Date 14-Feb-2025)
ApplicantSanofi-Aventis U.S. LLC
BLA761325
RouteSubcutaneous
Presentation
AutoinjectorMulti-Dose Vial
Merilog
insulin aspart-szjj
351(k) Biosimilar (Approval Date 14-Feb-2025)
ApplicantSanofi-Aventis U.S. LLC
BLA761325
·RouteSubcutaneous
Presentation
AutoinjectorMulti-Dose Vial