← FDA DRUG APPROVALS

FDA BLA · BLA103172

CATHFLO ACTIVASE

alteplase

Sponsor: GENENTECH

APPLICATION
BLA103172
TYPE
BLA
ORIGINAL APPROVAL
1987-11-13
LATEST ACTION
2022-09-01
ROUTE
INTRAVENOUS, SINGLE-USE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ACTIVASEPrescription
ALTEPLASE 50MG/VIAL · VIAL · SINGLE-USE
CATHFLO ACTIVASEPrescription
ALTEPLASE 2MG/VIAL · VIAL
ACTIVASEPrescription
ALTEPLASE 100MG/VIAL · VIAL · SINGLE-USE

Approval history

2022-09-01Labeling · Supplement 5268 · standard — Letter ↗AP
2020-10-08Labeling · Supplement 5267 · standard — Letter ↗AP
2018-02-28Labeling · Supplement 5260 · standard — Letter ↗AP
2018-02-28Labeling · Supplement 5259 · standard — Letter ↗AP
2017-06-30Labeling · Supplement 5253 · standard — Label ↗AP
2015-02-13Labeling · Supplement 5203 · standard — Review ↗AP
2005-01-04Efficacy · Supplement 5071 · standard — Label ↗AP
2002-05-15Supplement · Supplement 5009 — Label ↗AP
2001-09-04Efficacy · Supplement 5003 · standard — Label ↗AP
1996-06-18Efficacy · Supplement 1055 · priority — Review ↗AP
1995-04-03Efficacy · Supplement 1036 · priorityAP
1987-11-13Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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