Application 761174
- Type
- BLA
- Sponsor
- GLAXOSMITHKLINE
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761174 | Jemperli | dostarlimab-gxly | 351(a) | Rx | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | JEMPERLI | DOSTARLIMAB-GXLY | INJECTABLE;INJECTION | 500MG/10ML | 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 5 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0173-0898 | Jemperli | dostarlimab | GlaxoSmithKline LLC | BLA | Current |
| 0173-0898 | Jemperli | dostarlimab | GlaxoSmithKline LLC | BLA | Current |
| 0173-0898 | Jemperli | dostarlimab | GlaxoSmithKline LLC | BLA | Current |
| 0173-0898 | Jemperli | dostarlimab | GlaxoSmithKline LLC | BLA | Current |
| 0173-0898 | Jemperli | dostarlimab | GlaxoSmithKline LLC | BLA | Current |