Application 103909
- Type
- BLA
- Sponsor
- GENENTECH
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103909 | TNKase | tenecteplase | 351(a) | Rx | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TNKASE | TENECTEPLASE | VIAL | 50MG/VIAL | 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 |
|---|---|---|---|---|---|---|
| TNKase | TENECTEPLASE | Genentech, Inc. | e647640d-c395-4b4b-a0be-1162f9c21d84 | 2025-12-15 | Warnings, Adverse reactions | BLA103909 |
| TNKase | TENECTEPLASE | Genentech, Inc. | 739a3c53-caf6-40d6-a6af-84ce733a948b | 2025-12-15 | Warnings, Adverse reactions | BLA103909 50242-120 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-120 | TNKase | tenecteplase | Genentech, Inc. | BLA | Current |
| 50242-120 | TNKase | tenecteplase | Genentech, Inc. | BLA | Current |
| 50242-120 | TNKase | tenecteplase | Genentech, Inc. | BLA | Current |
| 50242-120 | TNKase | tenecteplase | Genentech, Inc. | BLA | Current |
| 50242-120 | TNKase | tenecteplase | Genentech, Inc. | BLA | Current |
| 50242-120 | TNKase | tenecteplase | Genentech, Inc. | BLA | Current |
| 50242-120 | TNKase | tenecteplase | Genentech, Inc. | BLA | Current |