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Granix
tbo-filgrastim
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Granix
Proper name
tbo-filgrastim
Licence type
351(a)
BLA number
125294
Applicant
UAB Teva Baltics
Center
CDER
Presentations
4
First licensure
August 29, 2012
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 300MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 29, 2012 |
| 300MCG/1ML | Injection | Subcutaneous | Single-Dose Vial | Rx | July 31, 2018 |
| 480MCG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 29, 2012 |
| 480MCG/1.6ML | Injection | Subcutaneous | Single-Dose Vial | Disc | July 31, 2018 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |