NDA 022574

BAYER HLTHCARE

FDA Drug Application

Application #022574

Documents

• Letter: 2010-12-21
• Letter: 2012-02-21
• Letter: 2015-06-03
• Label: 2012-02-14
• Label: 2012-04-10
• Label: 2015-06-04
• Review: 2016-02-03
• Other Important Information from FDA: 2011-11-16
• Letter: 2012-04-12
• Label: 2010-12-22
• Review: 2011-07-15
• Review: 2016-02-03
• Summary Review: 2011-07-15
• Label: 2017-08-09
• Letter: 2017-08-15
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2022-05-02
• Letter: 2022-05-03

Application Sponsors

NDA 022574

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

1

SAFYRAL

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2010-12-16	STANDARD
LABELING; Labeling	SUPPL	4	AP	2012-04-10	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-06-01	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-05-02	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	9	Null	6
SUPPL	11	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BAYER HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22574
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAFYRAL","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM","strength":"3MG,N\/A;0.03MG,N\/A;0.451MG,0.451MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/29\/2022","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022574s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022574s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022574s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022574s004lbl.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\\\/022574s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022574s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SAFYRAL","submission":"DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM","actionType":"3MG,N\/A;0.03MG,N\/A;0.451MG,0.451MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-04-29
        )

)