NDA 208224

BAYER HLTHCARE

FDA Drug Application

Application #208224

Documents

• Letter: 2016-09-20
• Label: 2016-09-20
• Review: 2017-10-26
• Label: 2018-03-02
• Letter: 2018-03-05
• Label: 2021-04-16
• Letter: 2021-04-27
• Letter: 2022-01-11
• Label: 2022-01-13

Application Sponsors

NDA 208224

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INTRAUTERINE DEVICE;INTRAUTERINE

19.5MG

1

KYLEENA

LEVONORGESTREL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2016-09-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-01-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	7

CDER Filings

BAYER HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208224
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"KYLEENA","activeIngredients":"LEVONORGESTREL","strength":"19.5MG","dosageForm":"INTRAUTERINE DEVICE;INTRAUTERINE","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/10\/2022","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/208224s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208224Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208224Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208224Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2018","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208224s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208224s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208224s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208224s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/16\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208224s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208224Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208224Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/10\/2022","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/208224s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/208224Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"04\/13\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208224Orig1s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/208224Orig1s002Advice_ltr2.pdf\"}]","notes":">"},{"actionDate":"03\/01\/2018","submission":"SUPPL-1","supplementCategories":"Labeling, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208224s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203159Orig1s010,208224Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-01-10
        )

)