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Novarel
chorionic gonadotropin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Novarel
Proper name
chorionic gonadotropin
Licence type
351(a)
BLA number
017016
Applicant
Ferring Pharmaceuticals Inc.
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 | Disc | January 15, 1974 |
| 15,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | February 15, 1985 |
| 2,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | December 27, 1984 |
| 2,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | February 16, 1990 |
| 20,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | January 15, 1974 |
| 5,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Rx | January 15, 1974 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |