Home PurpleBook 103909 TNKase Purple Book BLA 103909
BLA number 103909
Proprietary names TNKase
Proper names tenecteplase
Applicant Genentech, Inc.
Center CDER
First observed release 2020-05-01
Latest observed release 2026-06-01
Newest archive release 2026-06-01
FDA patent list No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage Present in newest release Latest Known Product Presentations# Product, Proprietary name, Proper name table Product Proprietary name Proper name License type Strength Dosage form Route Presentation Marketing Licensure Approval Patent list provided 001 TNKase tenecteplase 351(a) 50MG For Injection Intravenous Single-Dose Vial Rx Licensed 2000-06-02 002 TNKase tenecteplase 351(a) 25MG For Injection Intravenous Single-Dose Vial Rx Licensed 2025-02-28
Published Patent List# No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events# Release, Event, Product table Release Event Product Name License type Status Applicant 2025-03-01 N 002 TNKase 351(a) Rx Genentech, Inc. 2020-05-01 R 001 TNKase 351(a) Rx Genentech, Inc.
Observed Product State History# Release, Product, Name table Release Product Name License type Marketing Licensure Approval 2025-03-01 002 TNKase 351(a) Rx Licensed 2025-02-28 2020-05-01 001 TNKase 351(a) Rx Licensed 2000-06-02
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