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FDA BLA · BLA103909

TNKASE

tenecteplase

Sponsor: GENENTECH

APPLICATION
BLA103909
TYPE
BLA
ORIGINAL APPROVAL
2000-06-02
LATEST ACTION
2025-02-28
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

TNKASEPrescription
TENECTEPLASE 50MG/VIAL · VIAL

Approval history

2025-02-28Efficacy · Supplement 5197 · standard — Label ↗AP
2024-01-05Labeling · Supplement 5195 · standard — Label ↗AP
2023-03-31Labeling · Supplement 5194 · standard — Label ↗AP
2018-02-28Labeling · Supplement 5187 · standard — Letter ↗AP
2008-05-13Labeling · Supplement 5109 · standardAP
2000-06-02Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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