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Intron A
interferon alfa-2b
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Intron A
Proper name
interferon alfa-2b
Licence type
351(a)
BLA number
103132
Applicant
Merck Sharp & Dohme LLC
Center
CDER
Presentations
14
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MIU | For Injection | Subcutaneous, Intravenous, Intralesional, Intramuscular | Single-Dose Vial | Disc | June 4, 1986 |
| 10MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Single-Dose Vial | Disc | — |
| 10MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | — |
| 18MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Multi-Dose Vial | Disc | — |
| 18MIU | Injection | Subcutaneous, Intramuscular | Multi-Dose Vial | Disc | — |
| 25MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Multi-Dose Vial | Disc | June 4, 1986 |
| 25MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Multi-Dose Vial | Disc | — |
| 3MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | June 4, 1986 |
| 3MIU | Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | — |
| 3MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | — |
| 50MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | — |
| 5MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | June 4, 1986 |
| 5MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Single-Dose Vial | Disc | — |
| 5MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | — |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 21, 1995 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |