Skip to content
Application 103909
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TNKASE | TENECTEPLASE | VIAL | 50MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81419 | SUPPL | 2025-03-04 |
| 81383 | SUPPL | 2025-02-28 |
| 77242 | SUPPL | 2024-01-19 |
| 77237 | SUPPL | 2024-01-18 |
| 73939 | SUPPL | 2023-04-03 |
| 73921 | SUPPL | 2023-04-03 |
| 52968 | SUPPL | 2018-03-15 |
| 52803 | SUPPL | 2018-03-02 |
| 43290 | ORIG | 2004-03-29 |
| 39730 | ORIG | 2004-03-29 |
| 9489 | ORIG | 2004-03-29 |