NOVARTIS FDA Approval NDA 021802

NDA 021802

NOVARTIS

FDA Drug Application

Application #021802

Documents

Letter2006-04-13
Letter2006-08-04
Letter2007-05-01
Letter2009-12-11
Letter2009-12-11
Letter2010-11-22
Letter2012-05-04
Letter2013-12-13
Letter2015-04-20
Label2005-06-07
Label2006-04-12
Label2006-08-04
Label2009-10-30
Label2010-05-07
Label2010-11-19
Label2012-05-07
Label2015-04-21
Review2007-07-02
Other Important Information from FDA2007-05-10
Letter2005-06-07
Letter2006-04-13
Letter2006-08-04
Letter2008-10-22
Letter2010-05-07
Letter2013-06-12
Label2006-04-12
Label2006-08-04
Label2007-05-01
Label2009-10-30
Label2011-11-29
Label2013-06-18
Label2013-12-17
Label2017-01-06
Letter2017-01-10
Medication Guide2017-01-10
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2019-01-11
Label2019-01-11
Medication Guide2019-01-11
Medication Guide2019-01-11
Letter2019-01-18
Letter2019-01-18
Label2019-11-20
Medication Guide2019-11-20
Letter2019-11-20
Letter2021-06-29
Label2021-06-29
Medication Guide2021-06-29

Application Sponsors

NDA 021802NOVARTIS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007
Prescription008

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL5MG1FOCALIN XRDEXMETHYLPHENIDATE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL10MG1FOCALIN XRDEXMETHYLPHENIDATE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL20MG1FOCALIN XRDEXMETHYLPHENIDATE HYDROCHLORIDE
004CAPSULE, EXTENDED RELEASE;ORAL15MG1FOCALIN XRDEXMETHYLPHENIDATE HYDROCHLORIDE
005CAPSULE, EXTENDED RELEASE;ORAL30MG1FOCALIN XRDEXMETHYLPHENIDATE HYDROCHLORIDE
006CAPSULE, EXTENDED RELEASE;ORAL40MG1FOCALIN XRDEXMETHYLPHENIDATE HYDROCHLORIDE
007CAPSULE, EXTENDED RELEASE;ORAL35MG1FOCALIN XRDEXMETHYLPHENIDATE HYDROCHLORIDE
008CAPSULE, EXTENDED RELEASE;ORAL25MG1FOCALIN XRDEXMETHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2005-05-26STANDARD
LABELING; LabelingSUPPL3AP2006-08-01STANDARD
LABELING; LabelingSUPPL5AP2006-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2006-08-01N/A
LABELING; LabelingSUPPL9AP2007-04-25STANDARD
EFFICACY; EfficacySUPPL12AP2008-10-17UNKNOWN
EFFICACY; EfficacySUPPL14AP2009-10-23STANDARD
LABELING; LabelingSUPPL16AP2009-10-23STANDARD
LABELING; LabelingSUPPL17AP2010-05-04UNKNOWN
LABELING; LabelingSUPPL19AP2019-01-10STANDARD
LABELING; LabelingSUPPL21AP2010-11-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2011-04-21STANDARD
LABELING; LabelingSUPPL24AP2012-05-02STANDARD
LABELING; LabelingSUPPL25AP2013-06-11STANDARD
LABELING; LabelingSUPPL26AP2013-12-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2015-06-12STANDARD
LABELING; LabelingSUPPL28AP2015-04-17901 REQUIRED
LABELING; LabelingSUPPL29AP2019-01-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL31AP2015-12-04STANDARD
LABELING; LabelingSUPPL33AP2017-01-04901 REQUIRED
LABELING; LabelingSUPPL36AP2019-11-19STANDARD
LABELING; LabelingSUPPL39AP2021-06-26901 REQUIRED

Submissions Property Types

ORIG1Null31
SUPPL12Null6
SUPPL14Null7
SUPPL16Null0
SUPPL17Null6
SUPPL19Null15
SUPPL21Null7
SUPPL22Null0
SUPPL24Null6
SUPPL25Null6
SUPPL26Null6
SUPPL27Null0
SUPPL28Null6
SUPPL29Null6
SUPPL31Null0
SUPPL33Null7
SUPPL36Null6
SUPPL39Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB
008PrescriptionAB

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21802
            [companyName] => NOVARTIS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/021802s039lbl.pdf#page=18"]
            [products] => [{"drugName":"FOCALIN XR","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"FOCALIN XR","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"FOCALIN XR","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"FOCALIN XR","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"FOCALIN XR","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"FOCALIN XR","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"FOCALIN XR","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"35MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"FOCALIN XR","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/26\/2021","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021802s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2019","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021802s036lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021802s019s029lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021802s019s029lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021802s033lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021278s018,021802s028lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-26","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021802s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021802s026lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2013","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021802s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2012","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021802s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2011","submission":"SUPPL-22","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021802s022lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/15\/2010","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021802s021lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2010","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021802s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2010","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021802s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2009","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021802s014s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2009","submission":"SUPPL-14","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021802s014s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2007","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021278s008,021802s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2006","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021802s007s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2006","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021802s007s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2006","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021802s007s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2006","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021802s001,s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2006","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021802s001,s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021802lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FOCALIN XR","submission":"DEXMETHYLPHENIDATE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOCALIN XR","submission":"DEXMETHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOCALIN XR","submission":"DEXMETHYLPHENIDATE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOCALIN XR","submission":"DEXMETHYLPHENIDATE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOCALIN XR","submission":"DEXMETHYLPHENIDATE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOCALIN XR","submission":"DEXMETHYLPHENIDATE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOCALIN XR","submission":"DEXMETHYLPHENIDATE HYDROCHLORIDE","actionType":"35MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOCALIN XR","submission":"DEXMETHYLPHENIDATE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-06-26
        )

)
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