NDA 020899

GE HEALTHCARE

FDA Drug Application

Application #020899

Documents

• Letter: 2002-05-10
• Letter: 2007-11-19
• Letter: 2008-06-09
• Label: 2007-10-04
• Other Important Information from FDA: 2008-07-11
• Letter: 2012-08-20
• Label: 2008-06-12
• Label: 2012-08-20
• Label: 2016-09-16
• Label: 2016-09-16
• Letter: 2016-09-20
• Letter: 2016-09-20
• Letter: 2021-09-03
• Letter: 2021-09-20
• Label: 2021-09-20

Application Sponsors

NDA 020899

GE HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

1

OPTISON

ALBUMIN HUMAN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-12-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-02-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2000-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-05-10	STANDARD
LABELING; Labeling	SUPPL	10	AP	2007-11-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2008-06-06	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	2012-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2016-04-15	STANDARD
LABELING; Labeling	SUPPL	18	AP	2016-09-16	STANDARD
LABELING; Labeling	SUPPL	19	AP	2016-09-16	STANDARD
LABELING; Labeling	SUPPL	23	TA	2021-03-05	STANDARD
LABELING; Labeling	SUPPL	24	AP	2021-09-16	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	15	Null	7
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	15
SUPPL	19	Null	6
SUPPL	23	Null	15
SUPPL	24	Null	15

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20899
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"OPTISON","activeIngredients":"ALBUMIN HUMAN","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/16\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020899s018s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020899s018s019lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2012","submission":"SUPPL-15","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020899s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2008","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020899s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2002","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/020899s007lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"OPTISON","submission":"ALBUMIN HUMAN","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-09-16
        )

)