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Saizen
somatropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Saizen
Proper name
somatropin
Licence type
351(a)
BLA number
019764
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 | Single-Dose Vial | Disc | January 16, 2007 |
| 5MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | October 8, 1996 |
| 6MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | October 8, 1996 |
| 8.8MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | August 29, 2000 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |