Product Details for: Xyntha, Xyntha Solofuse

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
For Injection
Intravenous
2000IU
Pre-Filled Syringe
351(a)
Xyntha, Xyntha Solofuse
Rx
002
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Xyntha, Xyntha Solofuse
Rx
003
For Injection
Intravenous
1000IU
Pre-Filled Syringe
351(a)
Xyntha, Xyntha Solofuse
Rx
004
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Xyntha, Xyntha Solofuse
Rx
005
For Injection
Intravenous
250IU
Pre-Filled Syringe
351(a)
Xyntha, Xyntha Solofuse
Rx
006
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Xyntha, Xyntha Solofuse
Rx
007
For Injection
Intravenous
500IU
Pre-Filled Syringe
351(a)
Xyntha, Xyntha Solofuse
Rx
008
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Xyntha, Xyntha Solofuse
Rx
009
For Injection
Intravenous
3000IU
Pre-Filled Syringe
351(a)
Xyntha, Xyntha Solofuse
Rx
Proper Name
Antihemophilic Factor (Recombinant), Plasma/Albumin Free
BLA Number
125264
Applicant
Wyeth Pharmaceuticals LLC
Original Approval Date
February 21, 2008
Date of First Licensure
RETURN TO SEARCH RESULTS