JANSSEN PHARMS FDA Approval NDA 021123

NDA 021123

JANSSEN PHARMS

FDA Drug Application

Application #021123

Documents

Letter2011-06-28
Label2004-05-03
Label2011-06-29
Label2013-10-22
Letter2001-08-15
Letter2004-04-20
Letter2009-11-10
Letter2013-10-21
Label2001-08-15
Label2009-09-17
Review2001-08-15
Letter2016-12-20
Letter2016-12-20
Letter2016-12-20
Label2016-12-21
Label2016-12-21
Label2016-12-21
Label2017-08-30
Letter2017-08-30
Letter2018-09-28
Letter2018-09-28
Label2018-10-17
Label2018-10-17
Label2019-10-08
Medication Guide2019-10-08
Letter2019-10-08
Letter2021-03-05
Label2021-03-08
Medication Guide2021-03-08
Label2021-09-13
Medication Guide2021-09-13
Letter2021-09-14

Application Sponsors

NDA 021123JANSSEN PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL325MG;37.5MG1ULTRACETACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2001-08-15STANDARD
LABELING; LabelingSUPPL3AP2009-09-09STANDARD
LABELING; LabelingSUPPL5AP2011-06-22UNKNOWN
LABELING; LabelingSUPPL8AP2013-10-18901 REQUIRED
LABELING; LabelingSUPPL10AP2016-12-16STANDARD
LABELING; LabelingSUPPL12AP2016-12-16STANDARD
LABELING; LabelingSUPPL13AP2016-12-16STANDARD
LABELING; LabelingSUPPL14AP2017-08-29STANDARD
REMS; REMSSUPPL16AP2018-09-18N/A
LABELING; LabelingSUPPL17AP2018-09-18STANDARD
LABELING; LabelingSUPPL19AP2019-10-07STANDARD
LABELING; LabelingSUPPL20AP2021-03-04STANDARD
LABELING; LabelingSUPPL21AP2021-09-10STANDARD

Submissions Property Types

SUPPL3Null6
SUPPL5Null6
SUPPL8Null7
SUPPL10Null7
SUPPL12Null7
SUPPL13Null7
SUPPL14Null15
SUPPL16Null7
SUPPL17Null15
SUPPL19Null15
SUPPL20Null15
SUPPL21Null7

TE Codes

001PrescriptionAB

CDER Filings

JANSSEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21123
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/021123s021lbl.pdf#page=46"]
            [products] => [{"drugName":"ULTRACET","activeIngredients":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","strength":"325MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/10\/2021","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021123s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2021","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021123s020lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021123s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021123s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021123s016s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-16","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021123s016s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021123s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021123s010s012s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021123s010s012s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021123s010s012s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021123s010s012s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2013","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021123s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021123s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021123s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021123s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20281slr030,21123slr001_Ultram_lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21123lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ULTRACET","submission":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","actionType":"325MG;37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-09-10
        )

)
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