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Iplex
mecasermin rinfabate
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Iplex
Proper name
mecasermin rinfabate
Licence type
351(a)
BLA number
021884
Applicant
Insmed Incorporated
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 36MG/0.6ML (60MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Disc | December 12, 2005 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 12, 2012 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |