Product Details for: Novolin R
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1,000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(a)
Novolin R
OTC
002
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Novolin R
OTC
Proper Name
insulin human
insulin human
BLA Number
019938
019938
Applicant
Novo Nordisk Inc.
Novo Nordisk Inc.
Original Approval Date
June 25, 1991
June 25, 1991
Date of First Licensure