NOVEN PHARMS INC FDA Approval NDA 021514

NDA 021514

NOVEN PHARMS INC

FDA Drug Application

Application #021514

Documents

Letter2006-08-04
Letter2007-05-07
Letter2010-07-02
Label2006-08-04
Label2008-02-14
Label2010-07-06
Label2013-12-17
Label2015-04-21
Review2008-11-14
Letter2006-04-13
Letter2009-12-24
Letter2010-07-02
Letter2010-10-20
Letter2013-06-07
Letter2013-12-16
Letter2015-04-20
Letter2015-08-18
Label2008-02-14
Label2007-05-07
Label2008-02-14
Label2009-12-16
Label2010-10-18
Label2013-06-07
Label2015-08-17
Other Important Information from FDA2007-05-18
Label2016-08-23
Letter2016-08-19
Label2017-01-06
Letter2017-01-10
Letter2017-11-09
Label2017-11-14
Review2018-02-27
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Medical Review1900-01-01
Medication Guide2018-11-08
Letter2019-10-23
Label2019-10-28
Letter2021-06-29
Label2021-06-29
Medication Guide2021-06-29
Review2022-09-12

Application Sponsors

NDA 021514NOVEN PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL10MG/9HR (1.1MG/HR)1DAYTRANAMETHYLPHENIDATE
002FILM, EXTENDED RELEASE;TRANSDERMAL15MG/9HR (1.6MG/HR)1DAYTRANAMETHYLPHENIDATE
003FILM, EXTENDED RELEASE;TRANSDERMAL20MG/9HR (2.2MG/HR)1DAYTRANAMETHYLPHENIDATE
004FILM, EXTENDED RELEASE;TRANSDERMAL30MG/9HR (3.3MG/HR)1DAYTRANAMETHYLPHENIDATE

FDA Submissions

TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage FormORIG1AP2006-04-06STANDARD
LABELING; LabelingSUPPL3AP2008-02-05STANDARD
LABELING; LabelingSUPPL5AP2007-05-01STANDARD
LABELING; LabelingSUPPL6AP2008-02-05STANDARD
LABELING; LabelingSUPPL7AP2008-02-05STANDARD
LABELING; LabelingSUPPL8AP2009-12-15STANDARD
LABELING; LabelingSUPPL9AP2010-06-29STANDARD
EFFICACY; EfficacySUPPL10AP2010-06-29STANDARD
LABELING; LabelingSUPPL11AP2010-10-18UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2012-11-21STANDARD
LABELING; LabelingSUPPL15AP2013-06-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2013-05-09STANDARD
LABELING; LabelingSUPPL17AP2013-12-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2015-11-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2015-04-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2015-04-14STANDARD
LABELING; LabelingSUPPL22AP2015-04-17901 REQUIRED
LABELING; LabelingSUPPL23AP2015-08-14901 REQUIRED
LABELING; LabelingSUPPL24AP2016-08-19STANDARD
LABELING; LabelingSUPPL25AP2017-01-04901 REQUIRED
LABELING; LabelingSUPPL28AP2017-11-06STANDARD
LABELING; LabelingSUPPL30AP2019-10-22STANDARD
LABELING; LabelingSUPPL32AP2021-06-25901 REQUIRED

Submissions Property Types

ORIG1Null31
SUPPL8Null6
SUPPL9Null6
SUPPL10Null6
SUPPL11Null6
SUPPL14Null0
SUPPL15Null15
SUPPL16Null0
SUPPL17Null15
SUPPL18Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null6
SUPPL23Null6
SUPPL24Null7
SUPPL25Null15
SUPPL28Null7
SUPPL30Null6
SUPPL32Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

NOVEN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21514
            [companyName] => NOVEN PHARMS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/021514s028lbl.pdf#page=23"]
            [products] => [{"drugName":"DAYTRANA","activeIngredients":"METHYLPHENIDATE","strength":"10MG\/9HR (1.1MG\/HR)","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DAYTRANA","activeIngredients":"METHYLPHENIDATE","strength":"15MG\/9HR (1.6MG\/HR)","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DAYTRANA","activeIngredients":"METHYLPHENIDATE","strength":"20MG\/9HR (2.2MG\/HR)","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DAYTRANA","activeIngredients":"METHYLPHENIDATE","strength":"30MG\/9HR (3.3MG\/HR)","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/22\/2019","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021514s030lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021514s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021514s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021514s024lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2015","submission":"SUPPL-23","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021514s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2015","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021514s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021514s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021514s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021514s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021514s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2010","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021514s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2010","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021514s009s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2009","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021514s008lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2008","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021514s003s006s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2008","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021514s003s006s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2008","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021514s003s006s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2007","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021514s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2006","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021514s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DAYTRANA","submission":"METHYLPHENIDATE","actionType":"10MG\/9HR (1.1MG\/HR)","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DAYTRANA","submission":"METHYLPHENIDATE","actionType":"15MG\/9HR (1.6MG\/HR)","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DAYTRANA","submission":"METHYLPHENIDATE","actionType":"20MG\/9HR (2.2MG\/HR)","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DAYTRANA","submission":"METHYLPHENIDATE","actionType":"30MG\/9HR (3.3MG\/HR)","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-22
        )

)
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