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Mircera
methoxy polyethylene glycol-epoetin beta
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Mircera
Proper name
methoxy polyethylene glycol-epoetin beta
Licence type
351(a)
BLA number
125164
Applicant
Vifor (International) Inc.
Center
CDER
Presentations
19
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,000MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | November 14, 2007 |
| 100MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | November 14, 2007 |
| 100MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | November 14, 2007 |
| 120MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | April 28, 2016 |
| 150MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | November 14, 2007 |
| 200MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | November 14, 2007 |
| 200MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | November 14, 2007 |
| 250MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | November 14, 2007 |
| 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | November 14, 2007 |
| 30MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | April 28, 2016 |
| 360MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | April 28, 2016 |
| 400MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | November 14, 2007 |
| 400MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | November 14, 2007 |
| 50MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | November 14, 2007 |
| 50MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | November 14, 2007 |
| 600MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | November 14, 2007 |
| 600MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | November 14, 2007 |
| 75MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | November 14, 2007 |
| 800MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | November 14, 2007 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |