Product Details for: Kirsty
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(k) Interchangeable
Kirsty
Rx
002
Injection
Intravenous, Subcutaneous
1,000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(k) Interchangeable
Kirsty
Rx
Proper Name
insulin aspart-xjhz
insulin aspart-xjhz
Reference Product Proper Name
insulin aspart
insulin aspart
Reference Product Properietary Name
Novolog
Novolog
BLA Number
761188
761188
Applicant
Biocon Biologics Inc.
Biocon Biologics Inc.
Original Approval Date
July 15, 2025
July 15, 2025
Date of First Licensure