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Repronex
menotropins
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Repronex
Proper name
menotropins
Licence type
351(a)
BLA number
021047
Applicant
Ferring Pharmaceuticals Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | August 27, 1999 |
| 75IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | August 27, 1999 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |