Application 103836
- Type
- BLA
- Sponsor
- VIDARA THERAPEUTICS RESEARCH LTD
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103836 | Actimmune | interferon gamma-1b | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACTIMMUNE | INTERFERON GAMMA-1B | VIAL; SINGLE-USE | 100UG/0.5ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ACTIMMUNE | INTERFERON GAMMA-1B | Horizon Therapeutics USA, Inc. | 5d0b1256-1981-4519-94f4-a4a2f98bd8a3 | 2026-03-30 | Warnings, Adverse reactions | BLA103836 75987-111 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 75987-111 | ACTIMMUNE | Interferon gamma-1b | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-111 | ACTIMMUNE | Interferon gamma-1b | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-111 | ACTIMMUNE | Interferon gamma-1b | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-111 | ACTIMMUNE | Interferon gamma-1b | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-111 | ACTIMMUNE | Interferon gamma-1b | Horizon Pharma Inc. | BLA | Current |
| 75987-111 | ACTIMMUNE | Interferon gamma-1b | Horizon Therapeutics USA, Inc. | BLA | Current |