Product Details for: Nucala

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
100MG
Single-Dose Vial
351(a)
Nucala
Rx
002
Injection
Subcutaneous
100MG/ML
Autoinjector
351(a)
Nucala
Rx
003
Injection
Subcutaneous
100MG/ML
Pre-Filled Syringe
351(a)
Nucala
Rx
004
Injection
Subcutaneous
40MG/0.4ML
Pre-Filled Syringe
351(a)
Nucala
Rx
Proper Name
mepolizumab
BLA Number
761122
Applicant
GlaxoSmithKline LLC
Original Approval Date
June 6, 2019
Date of First Licensure
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