BAYER HLTHCARE FDA Approval NDA 201277

NDA 201277

BAYER HLTHCARE

FDA Drug Application

Application #201277

Documents

Letter2012-03-26
Letter2014-06-12
Letter2014-12-31
Letter2015-08-03
Letter2016-04-28
Label2015-09-21
Label2016-05-05
Review2011-04-11
Letter2011-03-16
Letter2013-10-18
Label2011-03-15
Label2013-10-21
Label2015-01-05
Summary Review2011-04-11
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-04-27
Letter2018-05-01
Pediatric Medical Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-07-27
Medication Guide2018-07-27
Letter2018-07-30
Label2018-11-06
Letter2018-11-15
Label2019-07-12
Medication Guide2019-07-12
Letter2019-07-15
Letter2020-07-31
Label2020-08-03
Medication Guide2020-08-03
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2022-05-20
Medication Guide2022-05-20

Application Sponsors

NDA 201277BAYER HLTHCARE

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001SOLUTION;INTRAVENOUS4.5354GM/7.5ML (604.72MG/ML)1GADAVISTGADOBUTROL
002SOLUTION;INTRAVENOUS6.0472GM/10ML (604.72MG/ML)1GADAVISTGADOBUTROL
003SOLUTION;INTRAVENOUS9.0708GM/15ML (604.72MG/ML)1GADAVISTGADOBUTROL
004SOLUTION;INTRAVENOUS18.1416GM/30ML (604.72MG/ML)1GADAVISTGADOBUTROL
005SOLUTION;INTRAVENOUS39.3068GM/65ML (604.72MG/ML)1GADAVISTGADOBUTROL
006SOLUTION;INTRAVENOUS1.20944GM/2ML (604.72MG/ML)1GADAVISTGADOBUTROL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2011-03-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2013-07-31STANDARD
LABELING; LabelingSUPPL3AP2013-10-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2013-12-18STANDARD
EFFICACY; EfficacySUPPL7AP2014-06-11STANDARD
EFFICACY; EfficacySUPPL8AP2014-12-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2015-06-01STANDARD
LABELING; LabelingSUPPL10AP2015-07-31STANDARD
EFFICACY; EfficacySUPPL11AP2016-04-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2015-11-25STANDARD
LABELING; LabelingSUPPL13AP2018-04-26STANDARD
LABELING; LabelingSUPPL15AP2018-07-26STANDARD
LABELING; LabelingSUPPL16AP2018-11-02STANDARD
EFFICACY; EfficacySUPPL17AP2019-07-12STANDARD
LABELING; LabelingSUPPL18AP2020-07-30STANDARD
LABELING; LabelingSUPPL20AP2022-04-27STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null0
SUPPL3Null15
SUPPL4Null0
SUPPL7Null7
SUPPL8Null7
SUPPL9Null0
SUPPL10Null15
SUPPL11Null15
SUPPL12Null0
SUPPL13Null6
SUPPL15Null15
SUPPL16Null6
SUPPL17Null6
SUPPL18Null7
SUPPL20Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
006PrescriptionAP

CDER Filings

BAYER HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201277
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/201277s020lbl.pdf#page=42"]
            [products] => [{"drugName":"GADAVIST","activeIngredients":"GADOBUTROL","strength":"4.5354GM\/7.5ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GADAVIST","activeIngredients":"GADOBUTROL","strength":"6.0472GM\/10ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GADAVIST","activeIngredients":"GADOBUTROL","strength":"9.0708GM\/15ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GADAVIST","activeIngredients":"GADOBUTROL","strength":"18.1416GM\/30ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"GADAVIST","activeIngredients":"GADOBUTROL","strength":"39.3068GM\/65ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"GADAVIST","activeIngredients":"GADOBUTROL","strength":"1.20944GM\/2ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/27\/2022","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/201277s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2022","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/201277s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201277s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201277s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2019","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201277s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201277s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022090s015,201277s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022090s015,201277s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201277s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2016","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201277s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201277s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2014","submission":"SUPPL-8","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201277s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201277s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201277s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/14\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201277s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/201277s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/201277Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/201277Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/27\/2022","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/201277s020lbl.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201277s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/201277Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"07\/12\/2019","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201277s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/201277Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201277s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/022090Orig1s016,201277Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"07\/26\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022090s015,201277s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/022090Orig1s015,201277Orig1s015Ltr.pdf\"}]","notes":">"},{"actionDate":"04\/26\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201277s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/201277Orig1s013Ltr.pdf\"}]","notes":">"},{"actionDate":"11\/25\/2015","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/27\/2016","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201277s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201277Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"07\/31\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201277s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201277Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"06\/01\/2015","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/29\/2014","submission":"SUPPL-8","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201277s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201277Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"06\/11\/2014","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201277Orig1s007ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/18\/2013","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/21\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201277s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201277Orig1s003ltr_replace.pdf\"}]","notes":">"},{"actionDate":"07\/31\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/22\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201277s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2022-04-27
        )

)
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