NDA 022252

BAYER HLTHCARE

FDA Drug Application

Application #022252

Documents

• Letter: 2010-05-12
• Letter: 2012-03-16
• Letter: 2015-08-24
• Label: 2010-05-17
• Label: 2012-02-14
• Label: 2013-08-22
• Review: 2010-06-06
• Summary Review: 2010-06-06
• Letter: 2012-02-15
• Letter: 2013-08-23
• Label: 2012-03-16
• Label: 2015-08-25
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2022-05-03
• Letter: 2022-05-03

Application Sponsors

NDA 022252

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A

1

NATAZIA

DIENOGEST; ESTRADIOL VALERATE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2010-05-06	STANDARD
EFFICACY; Efficacy	ORIG	2	AP	2012-03-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2013-08-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-08-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	31
ORIG	2	Null	6
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	7	Null	6

CDER Filings

BAYER HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22252
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NATAZIA","activeIngredients":"DIENOGEST; ESTRADIOL VALERATE","strength":"N\/A,2MG,3MG,N\/A,N\/A;3MG,2MG,2MG,1MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/29\/2022","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022252s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022252s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022252s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2012","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022252s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2012","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022252s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022252s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NATAZIA","submission":"DIENOGEST; ESTRADIOL VALERATE","actionType":"N\/A,2MG,3MG,N\/A,N\/A;3MG,2MG,2MG,1MG,N\/A","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-04-29
        )

)