Product Details for: Omnitrope

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
5.8MG
Multi-Dose Vial
351(a)
Omnitrope
Rx
002
For Injection
Subcutaneous
1.5MG
Single-Dose Vial
351(a)
Omnitrope
Disc
003
Injection
Subcutaneous
5MG/1.5ML
Multi-Dose Cartridge
351(a)
Omnitrope
Rx
004
Injection
Subcutaneous
10MG/1.5ML
Multi-Dose Cartridge
351(a)
Omnitrope
Rx
Proper Name
somatropin
BLA Number
021426
Applicant
Sandoz Inc.
Original Approval Date
May 30, 2006
Date of First Licensure
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