NDA 200179

BAYER HLTHCARE

FDA Drug Application

Application #200179

Documents

• Letter: 2013-08-05
• Letter: 2014-04-30
• Label: 2014-05-02
• Letter: 2010-06-21
• Letter: 2015-09-17
• Label: 2010-06-24
• Label: 2013-08-06
• Label: 2015-09-23
• Review: 2011-01-04
• Label: 2017-08-04
• Letter: 2017-08-04
• Label: 2017-08-17
• Letter: 2017-08-29

Application Sponsors

NDA 200179

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

10MG

1

STAXYN

VARDENAFIL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2010-06-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	2014-04-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-09-16	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2017-08-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-08-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	6
SUPPL	5	Null	6

TE Codes

001

Prescription

AB

CDER Filings

BAYER HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200179
            [companyName] => BAYER HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"STAXYN","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/16\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200179s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200179s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200179s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200179s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2013","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200179s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200179lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/17\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200179lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200179s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200179_staxyn_toc.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/16\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200179s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200179Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"08\/02\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/200179s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/200179Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/16\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200179s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200179Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"04\/29\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200179s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200179Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"08\/02\/2013","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200179s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200179Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2017-08-16
        )

)