BLA 017776

JUBILANT DRAXIMAGE

FDA Drug Application

Application #017776

Documents

• Other: 2020-03-23

Application Sponsors

BLA 017776

JUBILANT DRAXIMAGE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

PULMOLITE

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-07-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	1985-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-05-03	STANDARD
LABELING; Labeling	SUPPL	9	AP	1989-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-02-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-07-30	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17776
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)