LIEBEL-FLARSHEIM FDA Approval NDA 020976

NDA 020976

LIEBEL-FLARSHEIM

FDA Drug Application

Application #020976

Documents

Letter2007-09-06
Letter2010-12-22
Letter2013-05-23
Label1999-12-08
Label2006-08-07
Label2007-09-06
Label2010-12-20
Label2014-11-26
Review2004-01-29
Other Important Information from FDA2006-06-09
Letter1999-12-08
Letter2004-06-10
Letter2005-11-30
Letter2006-08-07
Letter2013-08-27
Letter2014-08-11
Letter2014-11-26
Label2004-06-10
Label2013-05-23
Label2013-08-27
Label2014-08-08
Review1999-12-08
Label2016-08-29
Label2018-04-27
Medication Guide2018-04-27
Letter2018-05-01
Label2018-11-06
Medication Guide2018-11-06
Letter2018-11-14

Application Sponsors

NDA 020976LIEBEL-FLARSHEIM

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001INJECTABLE;INJECTION9927MG/30ML (330.9MG/ML)1OPTIMARK IN PLASTIC CONTAINERGADOVERSETAMIDE
002INJECTABLE;INJECTION3309MG/10ML (330.9MG/ML)1OPTIMARK IN PLASTIC CONTAINERGADOVERSETAMIDE
003INJECTABLE;INJECTION4963.5MG/15ML (330.9MG/ML)1OPTIMARK IN PLASTIC CONTAINERGADOVERSETAMIDE
004INJECTABLE;INJECTION6618MG/20ML (330.9MG/ML)1OPTIMARK IN PLASTIC CONTAINERGADOVERSETAMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1999-12-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-01-29STANDARD
EFFICACY; EfficacySUPPL3AP2003-01-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-11-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2005-11-23STANDARD
EFFICACY; EfficacySUPPL9AP2006-08-04UNKNOWN
LABELING; LabelingSUPPL11AP2007-09-04STANDARD
LABELING; LabelingSUPPL16AP2010-12-20UNKNOWN
LABELING; LabelingSUPPL22AP2013-05-21STANDARD
LABELING; LabelingSUPPL24AP2013-08-26STANDARD
LABELING; LabelingSUPPL25AP2014-08-07STANDARD
LABELING; LabelingSUPPL26AP2014-11-24STANDARD
LABELING; LabelingSUPPL28AP2016-08-29STANDARD
LABELING; LabelingSUPPL29AP2018-04-26STANDARD
LABELING; LabelingSUPPL30AP2018-11-02STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL4Null0
SUPPL7Null0
SUPPL16Null7
SUPPL22Null7
SUPPL24Null7
SUPPL25Null7
SUPPL26Null31
SUPPL28Null7
SUPPL29Null15
SUPPL30Null6

CDER Filings

LIEBEL-FLARSHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20976
            [companyName] => LIEBEL-FLARSHEIM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020937s028,020975s029,020976s030lbl.pdf#page=43"]
            [products] => [{"drugName":"OPTIMARK IN PLASTIC CONTAINER","activeIngredients":"GADOVERSETAMIDE","strength":"9927MG\/30ML (330.9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OPTIMARK IN PLASTIC CONTAINER","activeIngredients":"GADOVERSETAMIDE","strength":"3309MG\/10ML (330.9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OPTIMARK IN PLASTIC CONTAINER","activeIngredients":"GADOVERSETAMIDE","strength":"4963.5MG\/15ML (330.9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OPTIMARK IN PLASTIC CONTAINER","activeIngredients":"GADOVERSETAMIDE","strength":"6618MG\/20ML (330.9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020937s028,020975s029,020976s030lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020976s029lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2016","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020937s026,020975s027,020976s028lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020937s02420975s2520976s26lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2014","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020937s023,020975s024,020976s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2013","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020975s2302976s24lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020937s021,020975s022,020976s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020976s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2007","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020937s011,020976s011,020975s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2006","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020937,020975,020976s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2003","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2003\\\/20-937S003_OptiMark_Prntlbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/20937_OptiMark_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OPTIMARK IN PLASTIC CONTAINER","submission":"GADOVERSETAMIDE","actionType":"9927MG\/30ML (330.9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OPTIMARK IN PLASTIC CONTAINER","submission":"GADOVERSETAMIDE","actionType":"3309MG\/10ML (330.9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OPTIMARK IN PLASTIC CONTAINER","submission":"GADOVERSETAMIDE","actionType":"4963.5MG\/15ML (330.9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OPTIMARK IN PLASTIC CONTAINER","submission":"GADOVERSETAMIDE","actionType":"6618MG\/20ML (330.9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-02
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.