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Nutropin
somatropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Nutropin
Proper name
somatropin
Licence type
351(a)
BLA number
020168
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | November 17, 1993 |
| 5MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | November 17, 1993 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 30, 2003 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |