Application 103836
- Type
- BLA
- Sponsor
- VIDARA THERAPEUTICS RESEARCH LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ACTIMMUNE | INTERFERON GAMMA-1B | VIAL; SINGLE-USE | 100UG/0.5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31692 | SUPPL | 2015-09-01 |
| 18670 | SUPPL | 2015-08-28 |
| 23944 | ORIG | 2007-03-09 |
| 39728 | SUPPL | 2007-02-23 |
| 31691 | SUPPL | 2007-02-12 |
| 39727 | SUPPL | 2004-12-06 |
| 31690 | SUPPL | 2004-12-06 |
| 31689 | SUPPL | 2004-03-10 |