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Nplate
romiplostim
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Nplate
Proper name
romiplostim
Licence type
351(a)
BLA number
125268
Applicant
Amgen Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 125MCG | For Injection | Subcutaneous | Single-Dose Vial | Rx | July 22, 2019 |
| 250MCG | For Injection | Subcutaneous | Single-Dose Vial | Rx | August 22, 2008 |
| 500MCG | For Injection | Subcutaneous | Single-Dose Vial | Rx | August 22, 2008 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | January 28, 2028 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |