NDA 203159

BAYER HLTHCARE

FDA Drug Application

Application #203159

Documents

• Letter: 2013-08-08
• Letter: 2013-09-17
• Letter: 2016-04-11
• Label: 2013-01-11
• Label: 2013-08-09
• Label: 2013-09-17
• Review: 2013-10-04
• Letter: 2013-01-11
• Label: 2016-04-12
• Summary Review: 2013-10-04
• Letter: 2016-11-03
• Label: 2016-11-04
• Label: 2016-12-21
• Letter: 2016-12-23
• Label: 2017-03-06
• Letter: 2017-03-08
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2018-03-02
• Letter: 2018-03-05
• Label: 2021-05-18
• Letter: 2021-05-19
• Letter: 2022-01-13
• Label: 2022-01-13

Application Sponsors

NDA 203159

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INTRAUTERINE DEVICE;INTRAUTERINE

13.5MG

1

SKYLA

LEVONORGESTREL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2013-01-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2013-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-05-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-04-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-11-02	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-03-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-12-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2018-03-01	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-05-17	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	6
SUPPL	3	Null	0
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	10	Null	6
SUPPL	12	Null	15
SUPPL	13	Null	6

CDER Filings

BAYER HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203159
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"SKYLA","activeIngredients":"LEVONORGESTREL","strength":"13.5MG","dosageForm":"INTRAUTERINE DEVICE;INTRAUTERINE","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/12\/2022","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/203159s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203159s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203159s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2021","submission":"SUPPL-12","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203159s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203159s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203159s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203159s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203159s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203159s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203159s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/13\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203159s002lbledt1.pdf\"}]","notes":""},{"actionDate":"08\/07\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203159s001lbledt1.pdf\"}]","notes":""},{"actionDate":"01\/09\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203159s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/09\/2013","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\\\/2013\\\/203159s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203159Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203159_skyla_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203159Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/12\/2022","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/203159s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/203159Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"05\/17\/2021","submission":"SUPPL-12","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\\\/203159s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/203159Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"03\/01\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203159s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203159Orig1s010,208224Orig1s001ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203159s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203159Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"03\/03\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203159s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203159Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203159s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203159Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"04\/08\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203159s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203159Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"05\/08\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203159s002lbledt1.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203159s002ltredt1.pdf\"}]","notes":">"},{"actionDate":"08\/07\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203159s001lbledt1.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203159s001ltredt1.pdf\"}]","notes":">"}]
            [actionDate] => 2022-01-12
        )

)