Application 761038
- Type
- BLA
- Sponsor
- ELI LILLY AND CO
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761038 | Lartruvo | olaratumab | 351(a) | Disc | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LARTRUVO | OLARATUMAB | INJECTABLE; INJECTION | 500MG/50ML | No | 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 4 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0002-7190 | LARTRUVO | olaratumab | Eli Lilly and Company | BLA | Current |
| 0002-7190 | LARTRUVO | olaratumab | Eli Lilly and Company | BLA | Current |
| 0002-8926 | LARTRUVO | olaratumab | Eli Lilly and Company | BLA | Current |
| 0002-8926 | LARTRUVO | olaratumab | Eli Lilly and Company | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 59621 | SUPPL | 2019-08-07 |
| 45966 | ORIG | 2016-11-29 |
| 45631 | ORIG | 2016-10-20 |
| 45627 | ORIG | 2016-10-19 |