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Albumin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
N/A
Proper name
Albumin (Human)
Licence type
351(a)
BLA number
101993
Applicant
Central Laboratory of the Netherlands Red Cross Blood Transfusion Service
Center
CBER
Presentations
338
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.25 | Injection | Intravenous | Multi-Dose Vial | Rx | September 7, 1979 |
| 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1,700MG/34ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | December 14, 2012 |
| 1.8MG/ML | Injection | Percutaneous | Vial | Disc | February 14, 1992 |
| 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | July 11, 2030 |
| 10,000AU/ML | Injection | Percutaneous | Dropper Vial | Disc | July 11, 2030 |
| 10,000AU/ML | Injection | Percutaneous | Dropper Vial | Rx | September 15, 1958 |
| 10,000AU/ML | Injection | Percutaneous | Dropper Vial | Rx | September 15, 1958 |
| 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000AU/ML | Injection | Percutaneous | Dropper Vial | Disc | July 11, 2030 |
| 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | July 11, 2030 |
| 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 10,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 10,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | September 15, 1958 |
| 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1958 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | July 11, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | September 15, 1958 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | December 16, 1971 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1958 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | July 11, 2030 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | December 16, 1971 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | June 14, 2030 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | May 29, 1997 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 25, 1997 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | September 15, 1958 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | June 14, 2030 |
| 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 100-800 MIL CFU | For Injection | Percutaneous | Single-Dose Vial | Rx | June 21, 1989 |
| 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | April 23, 2025 |
| 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 10G/50ML | Injection | Intravenous | Single-Use Bottle | Rx | September 27, 2007 |
| 10ML | For Injection | Intravenous | Vial | Disc | February 8, 1954 |
| 12.5G/250ML | Injection | Intravenous | Single-Use Bottle | Rx | October 17, 2006 |
| 12.5G/50ML | Injection | Intravenous | Single-Use Bottle | Rx | October 17, 2006 |
| 1:10W/V | Injection | Percutaneous | Dropper Vial | Disc | June 14, 2030 |
| 1:10W/V | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 1974 |
| 1:10W/V | Injection | Intradermal | Multi-Dose Vial | Disc | June 14, 2030 |
| 1:10W/V | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 1974 |
| 1:10W/V | Injection | Subcutaneous | Multi-Dose Vial | Disc | June 14, 2030 |
| 1:20W/V | Injection | Percutaneous | Dropper Vial | Rx | June 14, 2030 |
| 1:20W/V | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 1:20W/V | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 1:20W/V | Injection | Intradermal | Multi-Dose Vial | Rx | June 14, 2030 |
| 1:20W/V | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
| 1:20W/V | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 1:20W/V | Injection | Subcutaneous | Multi-Dose Vial | Rx | June 14, 2030 |
| 1:20W/V | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 1ML | Injection | Intradermal | Single-Dose Vial | Rx | January 2, 1959 |
| 2.5LF, 5LF, 2.5UG, 8UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | December 9, 1999 |
| 2.5LF, 5LF, 2.5UG, 8UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | December 9, 1999 |
| 2.5X10E7/KG CELL/ML | Injection | Intravenous | Bag | Rx | June 21, 2018 |
| 20G/100ML | Injection | Intravenous | Single-Use Bottle | Rx | September 27, 2007 |
| 25/LF/5LF/0.5ML | Injection | Intramuscular | Single-Dose Vial | Disc | February 24, 2000 |
| 25G/100ML | Injection | Intravenous | Single-Use Bottle | Rx | October 17, 2006 |
| 25G/500ML | Injection | Intravenous | Single-Use Bottle | Rx | October 17, 2006 |
| 2BIL. CELL/ML | Injection | Intramuscular | Single-Dose Vial | Disc | October 5, 1994 |
| 30,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 30,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 13, 2024 |
| 30,000AU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 30,000AU/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 30,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 30,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 30,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 30,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 300AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 300AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 30AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 30AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 13, 2024 |
| 4.5LOG 10TCID | Tablet | Oral | Bottle | Rx | March 16, 2011 |
| 5,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 5,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | March 12, 1974 |
| 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | March 12, 1974 |
| 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 5,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 5,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | March 12, 1974 |
| 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | March 12, 1974 |
| 5,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 15, 1958 |
| 5,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 5,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 15, 1958 |
| 5000IU | Injection | Intravenous | Vial | Rx | February 24, 2000 |
| 5G/100ML | Injection | Intravenous | Single-Use Bottle | Rx | October 17, 2006 |
| 5LF/.5ML | Injection | Intramuscular | Vial | Rx | December 9, 1999 |
| 5X10^8 NUCLEATED CELLS CONTENT WITH 85% VIABILITY & 1.25X10^6 VIABLE CD34+ CELLS (PRE-CRYOPRESERVATION) | Injection | Intravenous | Bag | Rx | January 28, 2016 |
| 5X10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25X10^6 VIABLE CD34+ CELLS | Injection | Intravenous | Bag | Rx | May 24, 2012 |
| 6.6; 5 UNITS | Injection | Intramuscular | Vial | Rx | December 9, 1999 |
| 6MG/ML | Injection | Percutaneous | Dropper Vial | Rx | March 13, 2024 |
| 90 MG/.5ML | Injection | Intramuscular | Vial | Disc | April 17, 2007 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 14, 2019 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |