Application 761126
- Type
- BLA
- Sponsor
- TANVEX BIOPHARMA USA INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761126 | Nypozi | filgrastim-txid | 351(k) Biosimilar | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NYPOZI | FILGRASTIM-TXID | INJECTABLE;INJECTION | 300MCG/0.5ML | No | No |
| 002 | NYPOZI | FILGRASTIM-TXID | INJECTABLE;INJECTION | 480MCG/0.8ML | 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 |
|---|---|---|---|---|---|---|
| NYPOZI txid | FILGRASTIM-TXID | Tanvex BioPharma USA, Inc. | 89092bb8-6a20-e23e-e053-2a95a90aa750 | 2026-01-15 | Warnings, Adverse reactions | BLA761126 |
| NYPOZI | FILGRASTIM-TXID | Cipla USA Inc. | 575d164d-45fa-4e3e-81e4-2652d96673d1 | 2025-05-01 | Warnings, Adverse reactions | BLA761126 |