Product Details for: Gammaplex

RETURN TO SEARCH RESULTS
PRODUCT LABEL Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
10G/200ML
Single-Dose Vial
351(a)
Gammaplex
Disc
002
Injection
Intravenous
2.5G/50ML
Single-Dose Vial
351(a)
Gammaplex
Disc
003
Injection
Intravenous
5G/100ML
Single-Dose Vial
351(a)
Gammaplex
Disc
004
Injection
Intravenous
20G/400ML
Single-Dose Vial
351(a)
Gammaplex
Disc
005
Injection
Intravenous
5G/50ML
Single-Dose Vial
351(a)
Gammaplex
Rx
006
Injection
Intravenous
10G/100ML
Single-Dose Vial
351(a)
Gammaplex
Rx
007
Injection
Intravenous
20G/200ML
Single-Dose Vial
351(a)
Gammaplex
Rx
Proper Name
Immune Globulin Intravenous (Human)
BLA Number
125329
Applicant
Bio Products Laboratory Limited
Original Approval Date
September 17, 2009
Date of First Licensure
RETURN TO SEARCH RESULTS