JANSSEN PHARMS FDA Approval NDA 021169

NDA 021169

JANSSEN PHARMS

FDA Drug Application

Application #021169

Documents

Letter2001-02-28
Letter2003-09-09
Letter2006-05-01
Letter2006-05-01
Letter2012-03-05
Letter2013-07-02
Letter2015-12-17
Label2001-02-28
Label2013-07-11
Label2012-05-01
Other Important Information from FDA2005-07-29
Letter2002-05-02
Letter2005-05-03
Letter2006-05-01
Letter2006-05-01
Letter2012-03-05
Letter2012-03-05
Letter2015-02-12
Label2012-03-06
Label2012-03-06
Label2015-02-10
Label2015-12-17
Review2001-12-18
Letter2017-02-16
Label2017-02-16
Letter2020-02-25
Label2020-02-27
Letter2020-03-23
Label2020-10-06
Letter2021-08-04
Label2021-08-04

Application Sponsors

NDA 021169JANSSEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 4MG BASE1RAZADYNEGALANTAMINE HYDROBROMIDE
002TABLET;ORALEQ 8MG BASE1RAZADYNEGALANTAMINE HYDROBROMIDE
003TABLET;ORALEQ 12MG BASE1RAZADYNEGALANTAMINE HYDROBROMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2001-02-28STANDARD
LABELING; LabelingSUPPL3AP2002-04-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-07-31STANDARD
LABELING; LabelingSUPPL7AP2003-09-03STANDARD
LABELING; LabelingSUPPL10AP2006-04-27STANDARD
LABELING; LabelingSUPPL11AP2005-05-02STANDARD
LABELING; LabelingSUPPL12AP2006-04-27STANDARD
LABELING; LabelingSUPPL13AP2006-04-27STANDARD
LABELING; LabelingSUPPL14AP2006-04-27STANDARD
LABELING; LabelingSUPPL16AP2012-03-01STANDARD
LABELING; LabelingSUPPL17AP2012-03-01STANDARD
LABELING; LabelingSUPPL24AP2013-06-28STANDARD
LABELING; LabelingSUPPL26AP2012-03-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2013-05-21STANDARD
LABELING; LabelingSUPPL30AP2015-02-09STANDARD
LABELING; LabelingSUPPL31AP2015-12-15STANDARD
LABELING; LabelingSUPPL32AP2017-02-14STANDARD
LABELING; LabelingSUPPL33AP2020-02-21STANDARD
LABELING; LabelingSUPPL34AP2020-03-20STANDARD
LABELING; LabelingSUPPL35AP2021-08-03STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL16Null7
SUPPL17Null7
SUPPL24Null15
SUPPL26Null15
SUPPL28Null0
SUPPL30Null7
SUPPL31Null7
SUPPL32Null15
SUPPL33Null6
SUPPL34Null15
SUPPL35Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

JANSSEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21169
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAZADYNE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RAZADYNE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RAZADYNE","activeIngredients":"GALANTAMINE HYDROBROMIDE","strength":"EQ 12MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/03\/2021","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021169s035,021615s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2020","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021169s034lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2020","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021169s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021169s033,021615s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2017","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021169Orig1s032,021224Orig1s030,021615Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2015","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021169s031-021224s029-021615s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2015","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021615s021lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021169s024,021224s022,021615s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021169s026,021224s025,021615s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021169s017,021224s015,021615s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021169s016,021224s014,021615s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21169lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RAZADYNE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RAZADYNE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RAZADYNE","submission":"GALANTAMINE HYDROBROMIDE","actionType":"EQ 12MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-08-03
        )

)
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