On this page
Gonal-f RFF RediJect
follitropin alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Gonal-f RFF RediJect
Proper name
follitropin alfa
Licence type
351(a)
BLA number
021684
Applicant
EMD Serono, Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 300IU/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | May 25, 2004 |
| 450IU/0.75ML | Injection | Subcutaneous | Autoinjector | Rx | May 25, 2004 |
| 900IU/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | May 25, 2004 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |