BAYER HLTHCARE FDA Approval NDA 020220

NDA 020220

BAYER HLTHCARE

FDA Drug Application

Application #020220

Documents

Letter2003-05-29
Letter2005-08-15
Letter2012-05-04
Letter2015-07-10
Label2010-01-08
Label2012-05-07
Label2015-07-09
Letter2004-03-16
Letter2007-09-06
Letter2010-01-05
Letter2010-01-20
Label2004-04-05
Label2007-09-04
Label2017-04-07
Label2017-04-12
Label2017-07-31
Letter2017-08-02
Letter2018-04-04
Label2018-04-04
Label2018-04-26
Letter2018-04-27
Label2019-08-02
Letter2019-08-02
Letter2022-02-22
Label2022-02-25

Application Sponsors

NDA 020220BAYER HLTHCARE

Marketing Status

Prescription001
Prescription002
Discontinued003
Discontinued004
Discontinued005

Application Products

001INJECTABLE;INJECTION76.9%1ULTRAVIST 370IOPROMIDE
002INJECTABLE;INJECTION62.3%1ULTRAVIST 300IOPROMIDE
003INJECTABLE;INJECTION49.9%1ULTRAVIST 240IOPROMIDE
004INJECTABLE;INJECTION31.2%1ULTRAVIST 150IOPROMIDE
005INJECTABLE;INJECTION62.3%1ULTRAVIST 300 IN PLASTIC CONTAINERIOPROMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1995-05-10STANDARD
EFFICACY; EfficacySUPPL2AP1997-07-23UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-06-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-11-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-11-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-12-27STANDARD
LABELING; LabelingSUPPL8AP2003-04-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-09-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-10-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2001-01-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-11-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2002-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2002-10-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2004-03-12STANDARD
LABELING; LabelingSUPPL22AP2005-08-12STANDARD
LABELING; LabelingSUPPL27AP2007-08-31STANDARD
EFFICACY; EfficacySUPPL33AP2009-12-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2009-11-13STANDARD
LABELING; LabelingSUPPL36AP2012-05-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2013-07-29STANDARD
LABELING; LabelingSUPPL41AP2015-07-06STANDARD
LABELING; LabelingSUPPL42AP2017-04-05STANDARD
LABELING; LabelingSUPPL43AP2017-07-27STANDARD
LABELING; LabelingSUPPL45AP2018-04-02STANDARD
LABELING; LabelingSUPPL46AP2018-04-24STANDARD
LABELING; LabelingSUPPL47AP2019-08-01STANDARD
LABELING; LabelingSUPPL52AP2022-02-18STANDARD

Submissions Property Types

SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL18Null0
SUPPL33Null7
SUPPL35Null0
SUPPL36Null15
SUPPL40Null0
SUPPL41Null15
SUPPL42Null31
SUPPL43Null6
SUPPL45Null15
SUPPL46Null6
SUPPL47Null6
SUPPL52Null7

CDER Filings

BAYER HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20220
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRAVIST 150","activeIngredients":"IOPROMIDE","strength":"31.2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ULTRAVIST 240","activeIngredients":"IOPROMIDE","strength":"49.9%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ULTRAVIST 300","activeIngredients":"IOPROMIDE","strength":"62.3%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ULTRAVIST 300 IN PLASTIC CONTAINER","activeIngredients":"IOPROMIDE","strength":"62.3%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ULTRAVIST 370","activeIngredients":"IOPROMIDE","strength":"76.9%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/18\/2022","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/020220s052,021425s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2019","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020220s047lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2018","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020220s046lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2018","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020220s045lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2017","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020220s043lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020220s042lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020220Orig1s042,021425Orig1s026ltr.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020220s041,021425s024lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2012","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020220s036lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2009","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020220s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2007","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020220s027lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2004","submission":"SUPPL-18","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20220scp018_ultravist_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ULTRAVIST 150","submission":"IOPROMIDE","actionType":"31.2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ULTRAVIST 240","submission":"IOPROMIDE","actionType":"49.9%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ULTRAVIST 300","submission":"IOPROMIDE","actionType":"62.3%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ULTRAVIST 300 IN PLASTIC CONTAINER","submission":"IOPROMIDE","actionType":"62.3%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ULTRAVIST 370","submission":"IOPROMIDE","actionType":"76.9%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-02-18
        )

)
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