NDA 019292

LIEBEL-FLARSHEIM

FDA Drug Application

Application #019292

Documents

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

Application Sponsors

NDA 019292

LIEBEL-FLARSHEIM

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

66%;10%

1

MD-76R

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-03-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	1992-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-08-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-07-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	1995-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2013-05-10	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-07-06	901 REQUIRED
LABELING; Labeling	SUPPL	11	AP	2017-04-05	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	15
SUPPL	11	Null	6

CDER Filings

LIEBEL-FLARSHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19292
            [companyName] => LIEBEL-FLARSHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MD-76R","activeIngredients":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","strength":"66%;10%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/05\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019292s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019292s010lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MD-76R","submission":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","actionType":"66%;10%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-04-05
        )

)