Application 761212
- Type
- BLA
- Sponsor
- LUPIN LTD
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761212 | Armlupeg | pegfilgrastim-unne | 351(k) Biosimilar | Rx | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ARMLUPEG | PEGFILGRASTIM-UNNE | INJECTION;SOLUTION | 6MG/0.6ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85273 | ORIG | 2026-03-05 |
| 85272 | ORIG | 2026-03-05 |
| 84343 | ORIG | 2025-12-01 |