Product Details for: Levemir

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1,000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(a)
Levemir
Disc
002
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Levemir
Disc
003
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Levemir
Disc
004
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Multi-Dose Cartridge
351(a)
Levemir
Disc
005
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Levemir
Disc
Proper Name
insulin detemir
BLA Number
021536
Applicant
Novo Nordisk Inc.
Original Approval Date
June 16, 2005
Date of First Licensure