Application 761143
- Type
- BLA
- Sponsor
- HORIZON THERAPEUTICS IRELAND
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761143 | Tepezza | teprotumumab-trbw | 351(a) | Rx | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TEPEZZA | TEPROTUMUMAB-TRBW | INJECTABLE;INJECTION | 500MG | Yes | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 5 matching rows.
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 |