Product Details for: Fiasp

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous, Subcutaneous
1000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(a)
Fiasp
Rx
002
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Fiasp
Rx
003
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Multi-Dose Cartridge
351(a)
Fiasp
Rx
004
Injection
Subcutaneous
160UNITS/1.6ML (100UNITS/ML)
Multi-Dose Cartridge
351(a)
Fiasp
Rx
Proper Name
insulin aspart
BLA Number
208751
Applicant
Novo Nordisk Inc.
Original Approval Date
September 29, 2017
Date of First Licensure
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