BLA 020304

BAYER HLTHCARE

FDA Drug Application

Application #020304

Documents

• Letter: 2020-03-23
• Letter: 2020-03-23
• Label: 2020-03-23
• Label: 2020-03-23
• Label: 2020-03-23
• Review: 2020-03-23
• Other Important Information from FDA: 2020-03-23
• Other: 2020-03-23

Application Sponsors

BLA 020304

BAYER HLTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10,000KIU/ML

0

TRASYLOL

APROTININ

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1993-12-29	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	1994-10-12	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1995-01-19	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1998-08-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	1997-08-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	1997-09-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	1999-03-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	1999-09-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	2000-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-04-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-09-18	PRIORITY
LABELING; Labeling	SUPPL	22	AP	2006-12-15	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	10	Null	14
SUPPL	11	Null	14

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 20304
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)