Product Details for: Saizen
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
6MG
Single-Dose Vial
351(a)
Saizen
Disc
002
For Injection
Subcutaneous
5MG
Single-Dose Vial
351(a)
Saizen
Disc
003
For Injection
Subcutaneous
8.8MG
Single-Dose Vial
351(a)
Saizen
Disc
005
For Injection
Subcutaneous
4MG
Single-Dose Vial
351(a)
Saizen
Disc
Proper Name
somatropin
somatropin
BLA Number
019764
019764
Applicant
EMD Serono, Inc.
EMD Serono, Inc.
Original Approval Date
October 8, 1996
October 8, 1996
Date of First Licensure