Product Details for: Raplixa

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Powder
Topical
0.5G
Vial
351(a)
Raplixa
Disc
002
Powder
Topical
1G
Vial
351(a)
Raplixa
Disc
003
Powder
Topical
2G
Vial
351(a)
Raplixa
Disc
Proper Name
Fibrin Sealant (Human)
BLA Number
125523
Applicant
Mallinckrodt Pharma IP Trading DAC
Original Approval Date
April 30, 2015
Date of First Licensure