Product Details for: Novoseven, Novoseven Rt
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PRODUCT LABEL
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
2.4MG
Single-Dose Vial
351(a)
Novoseven, Novoseven Rt
Disc
002
For Injection
Intravenous
1.2MG
Vial
351(a)
Novoseven, Novoseven Rt
Disc
003
For Injection
Intravenous
4.8MG
Vial
351(a)
Novoseven, Novoseven Rt
Disc
004
For Injection
Intravenous
5.0MG
Single-Dose Vial
351(a)
Novoseven, Novoseven Rt
Rx
005
For Injection
Intravenous
1.0MG
Single-Dose Vial
351(a)
Novoseven, Novoseven Rt
Rx
006
For Injection
Intravenous
2.0MG
Single-Dose Vial
351(a)
Novoseven, Novoseven Rt
Rx
007
For Injection
Intravenous
8.0MG
Single-Dose Vial
351(a)
Novoseven, Novoseven Rt
Rx
Proper Name
Coagulation Factor VIIa (Recombinant)
Coagulation Factor VIIa (Recombinant)
BLA Number
103665
103665
Applicant
Novo Nordisk Inc.
Novo Nordisk Inc.
Original Approval Date
March 25, 1999
March 25, 1999
Date of First Licensure