JANSSEN PHARMS FDA Approval NDA 021121

NDA 021121

JANSSEN PHARMS

FDA Drug Application

Application #021121

Documents

Letter2000-08-01
Letter2008-07-01
Letter2010-01-25
Letter2010-11-30
Letter2013-06-14
Label2000-08-01
Label2004-11-01
Label2007-05-07
Label2008-06-30
Label2008-06-30
Label2009-11-23
Label2010-12-01
Label2013-05-09
Label2013-12-17
Review2000-08-01
Review2011-09-22
Letter2002-04-01
Letter2004-10-29
Letter2006-09-18
Letter2006-09-18
Letter2007-05-09
Letter2008-07-01
Letter2010-11-30
Letter2013-05-07
Letter2013-12-16
Letter2015-04-21
Label2006-09-12
Label2006-09-12
Label2010-12-01
Label2013-06-18
Label2015-04-22
Review2007-06-22
Other Important Information from FDA2007-05-10
Label2017-01-06
Medication Guide2017-01-11
Letter2017-01-11
Review2017-05-17
Pediatric Medical Review1900-01-01
Pediatric Written Request1900-01-01
Pediatric Amendment 11900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2021-06-29
Label2021-06-29
Medication Guide2021-06-29

Application Sponsors

NDA 021121JANSSEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL18MG1CONCERTAMETHYLPHENIDATE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL36MG1CONCERTAMETHYLPHENIDATE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL54MG1CONCERTAMETHYLPHENIDATE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL27MG1CONCERTAMETHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2000-08-01STANDARD
LABELING; LabelingSUPPL2AP2001-04-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-03-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-04-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-12-18STANDARD
EFFICACY; EfficacySUPPL8AP2004-10-21PRIORITY
LABELING; LabelingSUPPL9AP2006-09-07STANDARD
LABELING; LabelingSUPPL12AP2006-09-07STANDARD
LABELING; LabelingSUPPL14AP2007-05-03STANDARD
LABELING; LabelingSUPPL15AP2008-06-27STANDARD
EFFICACY; EfficacySUPPL17AP2008-06-27UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2009-01-14N/A
EFFICACY; EfficacySUPPL22AP2009-11-04STANDARD
LABELING; LabelingSUPPL26AP2010-11-23UNKNOWN
LABELING; LabelingSUPPL27AP2010-11-23UNKNOWN
LABELING; LabelingSUPPL29AP2013-05-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2013-07-30STANDARD
LABELING; LabelingSUPPL31AP2013-06-12STANDARD
LABELING; LabelingSUPPL32AP2013-12-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2014-08-11STANDARD
LABELING; LabelingSUPPL35AP2015-04-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2016-11-30STANDARD
LABELING; LabelingSUPPL38AP2017-01-04901 REQUIRED
LABELING; LabelingSUPPL44AP2021-06-25901 REQUIRED

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL8Null6
SUPPL22Null7
SUPPL26Null6
SUPPL27Null6
SUPPL29Null15
SUPPL30Null0
SUPPL31Null6
SUPPL32Null7
SUPPL33Null0
SUPPL35Null7
SUPPL38Null15
SUPPL44Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

JANSSEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21121
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/021121s044lbl.pdf#page=30"]
            [products] => [{"drugName":"CONCERTA","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"18MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CONCERTA","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"36MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CONCERTA","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"54MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CONCERTA","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"27MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/25\/2021","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021121s044lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021121s038lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021121s035lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021121s032lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2013","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021121s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2013","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021121s029lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021121s026s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021121s026s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2009","submission":"SUPPL-22","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021121s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2008","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021121s015s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2008","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021121s015s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2007","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021121s014lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2006","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021121s009s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2006","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021121s009s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2004","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21121s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21121lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CONCERTA","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"18MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CONCERTA","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"36MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CONCERTA","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"54MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CONCERTA","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"27MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-06-25
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.