Product Details for: Ranluspec

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravitreal
6MG/ML (0.3MG/0.05ML)
Single-Dose Vial
351(k) Interchangeable
Ranluspec
Rx
002
Injection
Intravitreal
10MG/ML (0.5MG/0.05ML)
Single-Dose Vial
351(k) Interchangeable
Ranluspec
Rx
003
Injection
Intravitreal
6MG/ML (0.3MG/0.05ML)
Pre-Filled Syringe
351(k) Interchangeable
Ranluspec
Rx
004
Injection
Intravitreal
10MG/ML (0.5MG/0.05ML)
Pre-Filled Syringe
351(k) Interchangeable
Ranluspec
Rx
Proper Name
ranibizumab-hkdz
Reference Product Proper Name
ranibizumab
Reference Product Properietary Name
Lucentis
BLA Number
761480
Applicant
Lupin Limited (Biotech Division)
Original Approval Date
June 2, 2026
Date of First Licensure
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