Product Details for: Panzyga
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
1G ML
Single-Use Bottle
351(a)
Panzyga
Rx
002
Injection
Intravenous
2.5G ML
Single-Use Bottle
351(a)
Panzyga
Rx
003
Injection
Intravenous
30 G ML
Single-Use Bottle
351(a)
Panzyga
Rx
004
Injection
Intravenous
20G ML
Single-Use Bottle
351(a)
Panzyga
Rx
005
Injection
Intravenous
10G ML
Single-Use Bottle
351(a)
Panzyga
Rx
006
Injection
Intravenous
5G ML
Single-Use Bottle
351(a)
Panzyga
Rx
Proper Name
Immune Globulin Intravenous (Human)-ifas
Immune Globulin Intravenous (Human)-ifas
BLA Number
125587
125587
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Original Approval Date
August 2, 2018
August 2, 2018
Date of First Licensure