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Norditropin
somatropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Norditropin
Proper name
somatropin
Licence type
351(a)
BLA number
021148
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
11
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | June 20, 2000 |
| 10MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | October 1, 2004 |
| 10MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | March 1, 2010 |
| 15MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | June 20, 2000 |
| 15MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | October 1, 2004 |
| 15MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | March 1, 2010 |
| 30MG/3ML | Injection | Subcutaneous | Autoinjector | Disc | March 10, 2009 |
| 30MG/3ML | Injection | Subcutaneous | Autoinjector | Rx | January 23, 2015 |
| 5MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | June 20, 2000 |
| 5MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | October 1, 2004 |
| 5MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | March 1, 2010 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 31, 2014 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |