← FDA DRUG APPROVALS

FDA BLA · BLA021846

KINLYTIC

Sponsor: MICROBIX BIOSYSTEMS

APPLICATION
BLA021846
TYPE
BLA
ORIGINAL APPROVAL
1978-01-16
LATEST ACTION
2008-07-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

KINLYTICDiscontinued
UROKINASE 5,000 IU/VIAL · INJECTABLE · INJECTION
KINLYTICDiscontinued
UROKINASE 250,000 IU/VIAL · INJECTABLE · INJECTION
KINLYTICDiscontinued
UROKINASE 9,000 IU/VIAL · INJECTABLE · INJECTION

Approval history

2008-07-18Labeling · Supplement 101 · standard — Other ↗AP
2007-10-30Labeling · Supplement 99 · standard — Other ↗AP
2007-05-18Labeling · Supplement 98 · standard — Other ↗AP
1983-10-14Efficacy · Supplement 27AP
1983-06-30Labeling · Supplement 28AP
1982-01-22Labeling · Supplement 22AP
1981-09-23Labeling · Supplement 20AP
1981-04-20Efficacy · Supplement 17AP
1978-01-16UNKNOWN · Original · unknownAP
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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