Application 761212
- Type
- BLA
- Sponsor
- LUPIN LTD
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761212 | Armlupeg | pegfilgrastim-unne | 351(k) Biosimilar | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARMLUPEG | PEGFILGRASTIM-UNNE | INJECTION;SOLUTION | 6MG/0.6ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ARMLUPEG | PEGFILGRASTIM-UNNE | Lupin Pharmaceuticals, Inc. | c48fe1a7-63d7-4dce-bb53-a913cb0ade83 | 2026-07-23 | Warnings, Adverse reactions | BLA761212 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.