Product Details for: Opdivo

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
40MG/4ML (10MG/ML)
Single-Dose Vial
351(a)
Opdivo
Rx
002
Injection
Intravenous
100MG/10ML (10MG/ML)
Single-Dose Vial
351(a)
Opdivo
Rx
003
Injection
Intravenous
240MG/24ML (10MG/ML)
Single-Dose Vial
351(a)
Opdivo
Rx
004
Injection
Intravenous
120MG/12ML (10MG/ML)
Single-Dose Vial
351(a)
Opdivo
Rx
Proper Name
nivolumab
BLA Number
125554
Applicant
Bristol-Myers Squibb Company
Original Approval Date
December 22, 2014
Date of First Licensure
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