NDA 022014

PERRIGO PHARMA INTL

FDA Drug Application

Application #022014

Documents

• Label: 2007-07-30
• Label: 2008-04-16
• Other Important Information from FDA: 2010-08-09
• Letter: 2007-07-31
• Letter: 2008-04-16
• Letter: 2008-11-03
• Letter: 2014-03-13
• Letter: 2011-10-31
• Label: 2014-03-13
• Label: 2011-11-01
• Review: 2009-04-22
• Summary Review: 2009-04-22
• Label: 2017-11-02

Application Sponsors

NDA 022014

PERRIGO PHARMA INTL

Marketing Status

• Prescription: 001

Application Products

001

SPRAY;TRANSDERMAL

1.53MG/SPRAY

1

EVAMIST

ESTRADIOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2007-07-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2008-10-30	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-03-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2011-10-26	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-01-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-11-01	STANDARD

Submissions Property Types

SUPPL	6	Null	6
SUPPL	9	Null	7
SUPPL	12	Null	0
SUPPL	13	Null	6

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22014
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVAMIST","activeIngredients":"ESTRADIOL","strength":"1.53MG\/SPRAY","dosageForm":"SPRAY;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/01\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022014s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2014","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022014s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022014s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2008","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022014s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022014lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EVAMIST","submission":"ESTRADIOL","actionType":"1.53MG\/SPRAY","submissionClassification":"SPRAY;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-11-01
        )

)