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Chorionic Gonadotropin
chorionic gonadotropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Chorionic Gonadotropin
Proper name
chorionic gonadotropin
Licence type
351(a)
BLA number
017067
Applicant
Fresenius Kabi USA, LLC
Center
CDER
Presentations
6
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Rx | March 5, 1973 |
| 10,000UNITS | Injection | Intramuscular | Single-Dose Vial | Disc | March 26, 1974 |
| 15,0000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | March 5, 1973 |
| 20,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | March 5, 1973 |
| 5,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | March 5, 1973 |
| 5,000UNITS | Injection | Intramuscular | Single-Dose Vial | Disc | March 26, 1974 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |