Product Details for: Langlara
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(k) Interchangeable
Langlara
Rx
Proper Name
insulin glargine-aldy
insulin glargine-aldy
Reference Product Proper Name
insulin glargine
insulin glargine
Reference Product Properietary Name
Lantus
Lantus
BLA Number
761412
761412
Applicant
Sunshine Lake Pharma Co., Ltd.
Sunshine Lake Pharma Co., Ltd.
Original Approval Date
April 29, 2026
April 29, 2026
Date of First Licensure