NDA 016983

LIEBEL-FLARSHEIM

FDA Drug Application

Application #016983

Documents

• Letter: 2015-07-10
• Label: 2015-07-09
• Label: 2017-04-06
• Letter: 2017-04-12

Application Sponsors

NDA 016983

LIEBEL-FLARSHEIM

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

30%

1

CONRAY 30

IOTHALAMATE MEGLUMINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1971-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1975-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1976-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1976-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1976-05-05	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	1977-06-20
LABELING; Labeling	SUPPL	10	AP	1976-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1976-09-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	1982-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1981-08-24	STANDARD
LABELING; Labeling	SUPPL	15	AP	1982-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1984-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1984-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1989-06-28	STANDARD
LABELING; Labeling	SUPPL	19	AP	1984-11-07
EFFICACY; Efficacy	SUPPL	20	AP	1985-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1985-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1989-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1989-12-01	STANDARD
LABELING; Labeling	SUPPL	24	AP	1989-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1990-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1992-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1992-08-28	STANDARD
LABELING; Labeling	SUPPL	28	AP	1995-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1999-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2013-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2013-12-19	STANDARD
LABELING; Labeling	SUPPL	35	AP	2015-07-06	901 REQUIRED
LABELING; Labeling	SUPPL	37	AP	2017-04-05	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	0
SUPPL	35	Null	7
SUPPL	37	Null	7

CDER Filings

LIEBEL-FLARSHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16983
            [companyName] => LIEBEL-FLARSHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"CONRAY 30","activeIngredients":"IOTHALAMATE MEGLUMINE","strength":"30%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/05\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/016983s037lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/013295s068,016983s035lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CONRAY 30","submission":"IOTHALAMATE MEGLUMINE","actionType":"30%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-04-05
        )

)