Product Details for: Fiasp Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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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