Application 761143
- Type
- BLA
- Sponsor
- HORIZON THERAPEUTICS IRELAND
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TEPEZZA | TEPROTUMUMAB-TRBW | INJECTABLE;INJECTION | 500MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 75987-130 | TEPEZZA | teprotumumab | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-130 | TEPEZZA | teprotumumab | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-130 | TEPEZZA | teprotumumab | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-130 | TEPEZZA | teprotumumab | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-130 | TEPEZZA | teprotumumab | Horizon Therapeutics USA, Inc. | BLA | Current |