Product Details for: Granix

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
300MCG/0.5ML
Pre-Filled Syringe
351(a)
Granix
Rx
002
Injection
Subcutaneous
480MCG/0.8ML
Pre-Filled Syringe
351(a)
Granix
Rx
003
Injection
Subcutaneous
300MCG/1ML
Single-Dose Vial
351(a)
Granix
Rx
004
Injection
Subcutaneous
480MCG/1.6ML
Single-Dose Vial
351(a)
Granix
Disc
Proper Name
tbo-filgrastim
BLA Number
125294
Applicant
UAB Teva Baltics
Original Approval Date
August 29, 2012
Date of First Licensure
29-Aug-12
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