ANDA 208788

MYLAN

FDA Drug Application

Application #208788

Documents

• Letter: 2017-12-29

Application Sponsors

ANDA 208788

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

CREAM;VAGINAL

0.01%

0

ESTRADIOL

ESTRADIOL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-08-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208788
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.01%","dosageForm":"CREAM;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208788Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/27\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-08-27
        )

)