Product Details for: Zomacton
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
4.8MG
Multi-Dose Vial
351(a)
Zomacton
Disc
002
For Injection
Subcutaneous
5MG
Multi-Dose Vial
351(a)
Zomacton
Rx
003
For Injection
Subcutaneous
10MG
Multi-Dose Vial
351(a)
Zomacton
Rx
Proper Name
somatropin
somatropin
BLA Number
019774
019774
Applicant
Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc.
Original Approval Date
May 25, 1995
May 25, 1995
Date of First Licensure