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Acthrel
corticorelin ovine triflutate
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Acthrel
Proper name
corticorelin ovine triflutate
Licence type
351(a)
BLA number
020162
Applicant
Ferring Pharmaceuticals Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MCG | For Injection | Intravenous | Single-Dose Vial | Disc | May 23, 1996 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 23, 2003 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |