Product Details for: Humulin R U-100

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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)
Humulin R U-100
OTC
002
Injection
Subcutaneous
1,500UNITS/3ML (500UNITS/ML)
Autoinjector
351(a)
Humulin R U-500
Rx
003
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Humulin R U-100
Disc
004
Injection
Subcutaneous
10,000UNITS/20ML (500UNITS/ML)
Multi-Dose Vial
351(a)
Humulin R U-500
Rx
005
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Multi-Dose Vial
351(a)
Humulin R U-100
OTC
Proper Name
insulin human
BLA Number
018780
Applicant
Eli Lilly and Company
Original Approval Date
October 28, 1982
Date of First Licensure
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