BLA 019818

LEADIANT BIOSCI INC

FDA Drug Application

Application #019818

Documents

• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23

Application Sponsors

BLA 019818

LEADIANT BIOSCI INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

250 UNITS/ML

0

ADAGEN

PEGADEMASE BOVINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-03-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-06-10	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1991-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1992-04-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-04-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-03-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-12-28	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1992-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-08-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-06-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-12-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-09-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-08-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-04-15	PRIORITY
LABELING; Labeling	SUPPL	34	AP	2007-10-26	STANDARD
LABELING; Labeling	SUPPL	42	AP	2008-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2013-01-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2013-10-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2013-10-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2014-01-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	2013-12-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2014-03-04	PRIORITY
LABELING; Labeling	SUPPL	53	AP	2014-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2014-07-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	2015-12-21	PRIORITY

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	11	Null	14
SUPPL	13	Null	14
SUPPL	14	Null	14
SUPPL	17	Null	14
SUPPL	23	Null	14
SUPPL	24	Null	14
SUPPL	46	Null	14
SUPPL	47	Null	14
SUPPL	48	Null	14
SUPPL	50	Null	14
SUPPL	51	Null	14
SUPPL	52	Null	14
SUPPL	53	Null	7
SUPPL	55	Null	14
SUPPL	56	Null	14

CDER Filings

LEADIANT BIOSCI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19818
            [companyName] => LEADIANT BIOSCI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAGEN","activeIngredients":"PEGADEMASE BOVINE","strength":"250 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ADAGEN","submission":"PEGADEMASE BOVINE","actionType":"250 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)