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Serostim
somatropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Serostim
Proper name
somatropin
Licence type
351(a)
BLA number
020604
Applicant
EMD Serono, Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 4MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | July 25, 1997 |
| 5MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | August 23, 1996 |
| 6MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | August 23, 1996 |
| 6MG/0.5ML | Injection | Subcutaneous | Single-Dose Cartridge | Disc | February 11, 2005 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 23, 2003 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |