Product Details for: Orencia

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
250MG
Single-Dose Vial
351(a)
Orencia
Rx
002
Injection
Subcutaneous
125MG/ML
Pre-Filled Syringe
351(a)
Orencia
Rx
003
Injection
Subcutaneous
125MG/ML
Autoinjector
351(a)
Orencia
Rx
004
Injection
Subcutaneous
50MG/0.4ML
Pre-Filled Syringe
351(a)
Orencia
Rx
005
Injection
Subcutaneous
87.5MG/0.7ML
Pre-Filled Syringe
351(a)
Orencia
Rx
Proper Name
abatacept
BLA Number
125118
Applicant
Bristol-Myers Squibb Company
Original Approval Date
December 23, 2005
Date of First Licensure
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