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Cutaquig
Immune Globulin Subcutaneous (Human)-hipp
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Cutaquig
Proper name
Immune Globulin Subcutaneous (Human)-hipp
Licence type
351(a)
BLA number
125668
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Center
CBER
Presentations
6
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1.65G/10 ML | Solution | Subcutaneous | Single-Dose Vial | Rx | December 12, 2018 |
| 1G/6ML | Solution | Subcutaneous | Vial | Rx | December 12, 2018 |
| 2G/12ML | Solution | Subcutaneous | Single-Dose Vial | Rx | December 12, 2018 |
| 3.3G/20 ML | Solution | Subcutaneous | Single-Dose Vial | Rx | December 12, 2018 |
| 4G/24ML | Solution | Subcutaneous | Single-Dose Vial | Rx | December 12, 2018 |
| 8G/48ML | Solution | Subcutaneous | Single-Dose Vial | Rx | December 12, 2018 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |