On this page
Omnitrope
somatropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Omnitrope
Proper name
somatropin
Licence type
351(a)
BLA number
021426
Applicant
Sandoz Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1.5MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | May 30, 2006 |
| 10MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | August 25, 2008 |
| 5.8MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | May 30, 2006 |
| 5MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | January 16, 2008 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |