FDA BLA · BLA020304

TRASYLOL

Sponsor: BAYER HLTHCARE

APPLICATION

BLA020304

TYPE

BLA

ORIGINAL APPROVAL

1993-12-29

LATEST ACTION

2006-12-15

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

TRASYLOLDiscontinued

APROTININ 10,000KIU/ML · INJECTABLE · INJECTION

2006-12-15Labeling · Supplement 22 · standard — Label ↗AP

2001-09-18Manufacturing (CMC) · Supplement 11 · priorityAP

2001-04-11Manufacturing (CMC) · Supplement 10 · priorityAP

2000-07-24Labeling · Supplement 9 · standard — Label ↗AP

1999-09-21Labeling · Supplement 8 · standardAP

1999-03-05Labeling · Supplement 7 · standardAP

1998-08-28Efficacy · Supplement 4 · standard — Letter ↗AP

1997-09-30Labeling · Supplement 6 · standardAP

1997-08-08Labeling · Supplement 5 · standardAP

1995-01-19Labeling · Supplement 3 · standardAP

1994-10-12Efficacy · Supplement 2 · priorityAP

1994-02-07Manufacturing (CMC) · Supplement 1 · priorityAP

1993-12-29Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP

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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