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Genotropin
somatropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Genotropin
Proper name
somatropin
Licence type
351(a)
BLA number
020280
Applicant
Pharmacia & Upjohn Company LLC
Center
CDER
Presentations
13
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 0.4MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 0.6MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 0.8MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 1.2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 1.4MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 1.5MG | For Injection | Subcutaneous | Pre-Filled Syringe | Disc | August 24, 1995 |
| 1.6MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 1.8MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 12MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | October 23, 1996 |
| 1MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 27, 1998 |
| 5MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | August 24, 1995 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | July 25, 2008 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |