JUBILANT DRAXIMAGE FDA Approval NDA 021305

NDA 021305

JUBILANT DRAXIMAGE

FDA Drug Application

Application #021305

Documents

Letter2003-01-24
Letter2003-08-15
Letter2004-12-02
Letter2005-05-20
Letter2006-10-26
Letter2008-03-04
Letter2011-10-05
Letter2016-06-21
Letter2016-07-12
Label2003-01-24
Label2005-05-20
Label2006-01-10
Label2011-10-03
Label2016-06-21
Review2003-06-26
Letter2006-01-20
Letter2007-04-25
Letter2011-09-28
Label2007-04-20
Label2008-03-05
Label2011-09-29
Label2021-06-14
Letter2021-06-15

Application Sponsors

NDA 021305JUBILANT DRAXIMAGE

Marketing Status

Discontinued002
Discontinued003
Discontinued004
Discontinued005
Prescription006
Prescription007

Application Products

002SOLUTION;ORAL1-250mCi/0.25ML0HICONSODIUM IODIDE I-131
003SOLUTION;ORAL1-500mCi/0.5ML0HICONSODIUM IODIDE I-131
004CAPSULE;ORAL2-200mCi0SODIUM IODIDE I 131SODIUM IODIDE I-131
005SOLUTION;ORAL1-1000mCi/ML0HICONSODIUM IODIDE I-131
006CAPSULE;ORAL0.009-0.1mCi1SODIUM IODIDE I 131SODIUM IODIDE I-131
007SOLUTION;ORAL250-1000mCi1HICONSODIUM IODIDE I-131

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2003-01-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2004-11-18STANDARD
EFFICACY; EfficacySUPPL3AP2005-05-19UNKNOWN
LABELING; LabelingSUPPL5AP2006-01-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2006-04-04N/A
LABELING; LabelingSUPPL10AP2006-10-23STANDARD
LABELING; LabelingSUPPL11AP2007-04-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2008-01-17N/A
LABELING; LabelingSUPPL16AP2008-02-29STANDARD
LABELING; LabelingSUPPL25AP2011-09-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2011-10-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2012-12-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL34AP2012-12-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2014-09-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2015-02-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2016-04-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2015-07-31STANDARD
LABELING; LabelingSUPPL41AP2016-06-15STANDARD
LABELING; LabelingSUPPL42AP2016-07-08STANDARD
LABELING; LabelingSUPPL47AP2021-06-11STANDARD

Submissions Property Types

ORIG1Null31
SUPPL2Null0
SUPPL25Null6
SUPPL27Null0
SUPPL33Null0
SUPPL34Null0
SUPPL35Null0
SUPPL38Null0
SUPPL39Null0
SUPPL40Null0
SUPPL41Null6
SUPPL42Null7
SUPPL47Null7

TE Codes

007PrescriptionAA

CDER Filings

JUBILANT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21305
            [companyName] => JUBILANT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HICON","activeIngredients":"SODIUM IODIDE I-131","strength":"1-250mCi\/0.25ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HICON","activeIngredients":"SODIUM IODIDE I-131","strength":"1-500mCi\/0.5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HICON","activeIngredients":"SODIUM IODIDE I-131","strength":"1-1000mCi\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HICON","activeIngredients":"SODIUM IODIDE I-131","strength":"250-1000mCi","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"SODIUM IODIDE I 131","activeIngredients":"SODIUM IODIDE I-131","strength":"2-200mCi","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM IODIDE I 131","activeIngredients":"SODIUM IODIDE I-131","strength":"0.009-0.1mCi","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/11\/2021","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021305Orig1s047lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2016","submission":"SUPPL-41","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021305s041lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2011","submission":"SUPPL-27","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021305s027lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"09\/23\/2011","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021305s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/29\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021305s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2007","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021305s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/06\/2006","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021305s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2005","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021305s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21305_Sodium-Iodide_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HICON","submission":"SODIUM IODIDE I-131","actionType":"1-250mCi\/0.25ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HICON","submission":"SODIUM IODIDE I-131","actionType":"1-500mCi\/0.5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HICON","submission":"SODIUM IODIDE I-131","actionType":"1-1000mCi\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HICON","submission":"SODIUM IODIDE I-131","actionType":"250-1000mCi","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SODIUM IODIDE I 131","submission":"SODIUM IODIDE I-131","actionType":"2-200mCi","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SODIUM IODIDE I 131","submission":"SODIUM IODIDE I-131","actionType":"0.009-0.1mCi","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-06-11
        )

)
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