Application 761081
- Type
- BLA
- Sponsor
- PFIZER INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761081 | Trazimera | trastuzumab-qyyp | 351(k) Biosimilar | Rx | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAZIMERA | TRASTUZUMAB-QYYP | INJECTABLE;INJECTION | 420MG | 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 |
|---|---|---|---|---|---|---|
| Trazimera | TRASTUZUMAB-QYYP | Pfizer Laboratories Div Pfizer Inc | b9c5e894-27d2-4245-a653-df986fed3c56 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | BLA761081 0069-0308 0069-0305 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0305 | Trazimera-qyyp | trastuzumab | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0305 | Trazimera | trastuzumab-qyyp | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0305 | Trazimera | trastuzumab-qyyp | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0305 | Trazimera | trastuzumab-qyyp | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0305 | Trazimera-qyyp | trastuzumab | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0305 | Trazimera | trastuzumab-qyyp | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0308 | Trazimera | trastuzumab-qyyp | Pfizer Laboratories Div Pfizer Inc | BLA | Current |
| 0069-0308 | Trazimera | trastuzumab-qyyp | Pfizer Laboratories Div Pfizer Inc | BLA | Current |