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Zorbtive/Serostim
somatropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Zorbtive/Serostim
Proper name
somatropin
Licence type
351(a)
BLA number
020604
Applicant
EMD Serono, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 8.8MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | November 19, 2001 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |