Product Details for: Cutaquig
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Solution
Subcutaneous
1.65G/10 ML
Single-Dose Vial
351(a)
Cutaquig
Rx
002
Solution
Subcutaneous
3.3G/20 ML
Single-Dose Vial
351(a)
Cutaquig
Rx
003
Solution
Subcutaneous
1G/6ML
Vial
351(a)
Cutaquig
Rx
004
Solution
Subcutaneous
2G/12ML
Single-Dose Vial
351(a)
Cutaquig
Rx
005
Solution
Subcutaneous
8G/48ML
Single-Dose Vial
351(a)
Cutaquig
Rx
006
Solution
Subcutaneous
4G/24ML
Single-Dose Vial
351(a)
Cutaquig
Rx
Proper Name
Immune Globulin Subcutaneous (Human)-hipp
Immune Globulin Subcutaneous (Human)-hipp
BLA Number
125668
125668
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Original Approval Date
December 12, 2018
December 12, 2018
Date of First Licensure