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Pharmalgen
Venoms, Honey Bee Venom
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Pharmalgen
Proper name
Venoms, Honey Bee Venom
Licence type
351(a)
BLA number
103969
Applicant
ALK - Abello A/S
Center
CBER
Presentations
12
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | October 8, 1991 |
| 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | October 8, 1991 |
| 300UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | October 8, 1991 |
| 300UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | October 8, 1991 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |