Product Details for: Apidra
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous, Subcutaneous
1,000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(a)
Apidra
Rx
002
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Multi-Dose Cartridge
351(a)
Apidra
Disc
003
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Apidra
Rx
Proper Name
insulin glulisine
insulin glulisine
BLA Number
021629
021629
Applicant
Sanofi-Aventis U.S. LLC
Sanofi-Aventis U.S. LLC
Original Approval Date
April 16, 2004
April 16, 2004
Date of First Licensure