BAYER HLTHCARE FDA Approval NDA 205352

NDA 205352

BAYER HLTHCARE

FDA Drug Application

Application #205352

Documents

Letter2014-01-17
Letter2015-07-16
Label2014-01-28
Label2014-09-23
Label2015-07-22
Label2015-08-26
Review2015-05-14
Letter2014-09-03
Letter2014-11-24
Letter2015-02-27
Letter2015-08-18
Letter2015-10-30
Letter2015-12-30
Label2015-01-08
Label2015-03-12
Label2015-10-29
Summary Review2015-05-14
Letter2017-09-15
Label2017-09-21
Letter2018-01-17
Label2018-01-18
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2018-08-28
Label2018-08-29
Letter2019-04-11
Label2019-04-11
Letter2020-04-07
Label2020-04-07
Letter2020-11-03
Label2020-11-30
Label2022-02-09
Letter2022-02-09

Application Sponsors

NDA 205352BAYER HLTHCARE

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL25MG;220MG1ALEVE PMDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2014-01-17STANDARD
LABELING; LabelingSUPPL2AP2014-11-20STANDARD
LABELING; LabelingSUPPL3AP2015-02-25STANDARD
LABELING; LabelingSUPPL4AP2015-07-15STANDARD
LABELING; LabelingSUPPL5AP2015-08-14STANDARD
LABELING; LabelingSUPPL6AP2015-10-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2015-12-23STANDARD
LABELING; LabelingSUPPL9AP2017-09-12STANDARD
LABELING; LabelingSUPPL10AP2018-01-16STANDARD
LABELING; LabelingSUPPL11AP2018-08-28STANDARD
LABELING; LabelingSUPPL13AP2019-04-10STANDARD
LABELING; LabelingSUPPL14AP2020-04-06STANDARD
LABELING; LabelingSUPPL15AP2020-10-30STANDARD
LABELING; LabelingSUPPL16AP2022-02-08STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null15
SUPPL3Null6
SUPPL4Null6
SUPPL5Null6
SUPPL6Null7
SUPPL7Null0
SUPPL9Null7
SUPPL11Null7
SUPPL13Null7
SUPPL14Null7
SUPPL15Null7
SUPPL16Null15

CDER Filings

BAYER HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205352
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALEVE PM","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM","strength":"25MG;220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/08\/2022","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205352Orig1s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2020","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205352Orig1s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205352Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205352Orig1s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205352s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2018","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205352Orig1s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205352Orig1s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205352Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205352Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205352Orig1s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205352Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205352Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205352Orig1s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205352Orig1s000lbl_corrected.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/17\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205352Orig1s000lbl_corrected.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205352Orig1s000ltr_corrected.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205352Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205352Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/08\/2022","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/205352Orig1s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/205352Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"10\/30\/2020","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205352Orig1s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205352Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"04\/06\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205352Orig1s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205352Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"04\/10\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205352Orig1s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205352Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205352s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205352Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"01\/16\/2018","submission":"SUPPL-10","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205352Orig1s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205352Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205352Orig1s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205352Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/23\/2015","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205352Orig1s007ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/28\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205352Orig1s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205352Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"08\/14\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205352Orig1s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205352Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"07\/15\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205352Orig1s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205352Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/25\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205352Orig1s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205352Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"11\/20\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205352Orig1s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205352Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205352Orig1s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205352Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-02-08
        )

)
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