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Ovidrel
choriogonadotropin alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Ovidrel
Proper name
choriogonadotropin alfa
Licence type
351(a)
BLA number
021149
Applicant
EMD Serono, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 250MCG | Injection | Subcutaneous | Single-Dose Vial | Disc | September 20, 2000 |
| 250MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | July 14, 2003 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |