NDA 202153

JUBILANT DRAXIMAGE

FDA Drug Application

Application #202153

Documents

• Letter: 2016-10-05
• Label: 2016-10-24
• Review: 2017-02-08
• Label: 2019-04-26
• Letter: 2019-04-30

Application Sponsors

NDA 202153

JUBILANT DRAXIMAGE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

N/A

0

RUBY-FILL

RUBIDIUM CHLORIDE RB-82

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2016-09-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-04-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	12	Null	15

CDER Filings

JUBILANT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202153
            [companyName] => JUBILANT
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUBY-FILL","activeIngredients":"RUBIDIUM CHLORIDE RB-82","strength":"N\/A","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/26\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202153s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202153s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202153s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202153s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202153Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/202153Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/26\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202153s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/202153Orig1s012ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-04-26
        )

)