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Apidra
insulin glulisine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Apidra
Proper name
insulin glulisine
Licence type
351(a)
BLA number
021629
Applicant
Sanofi-Aventis U.S. LLC
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | April 16, 2004 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | December 20, 2005 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | February 24, 2009 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |