Product Details for: Skytrofa

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
3MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
002
For Injection
Subcutaneous
3.6MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
003
For Injection
Subcutaneous
4.3MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
004
For Injection
Subcutaneous
5.2MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
005
For Injection
Subcutaneous
6.3MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
006
For Injection
Subcutaneous
7.6MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
007
For Injection
Subcutaneous
9.1MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
008
For Injection
Subcutaneous
11MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
009
For Injection
Subcutaneous
13.3MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
010
For Injection
Subcutaneous
0.7MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
011
For Injection
Subcutaneous
1.4MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
012
For Injection
Subcutaneous
1.8MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
013
For Injection
Subcutaneous
2.1MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
014
For Injection
Subcutaneous
2.5MG
Single-Dose Cartridge
351(a)
Skytrofa
Rx
Proper Name
lonapegsomatropin-tcgd
BLA Number
761177
Applicant
Ascendis Pharma Endocrinology Division A/S
Original Approval Date
August 25, 2021
Date of First Licensure
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