Product Details for: Somavert
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
10MG
Single-Dose Vial
351(a)
Somavert
Rx
002
For Injection
Subcutaneous
15MG
Single-Dose Vial
351(a)
Somavert
Rx
003
For Injection
Subcutaneous
20MG
Single-Dose Vial
351(a)
Somavert
Rx
004
For Injection
Subcutaneous
25MG
Single-Dose Vial
351(a)
Somavert
Rx
005
For Injection
Subcutaneous
30MG
Single-Dose Vial
351(a)
Somavert
Rx
Proper Name
pegvisomant
pegvisomant
BLA Number
021106
021106
Applicant
Pharmacia & Upjohn Company LLC
Pharmacia & Upjohn Company LLC
Original Approval Date
March 25, 2003
March 25, 2003
Date of First Licensure