NDA 021371

EXELTIS USA INC

FDA Drug Application

Application #021371

Documents

• Review: 2005-01-11
• Letter: 2003-10-16
• Letter: 2015-03-12
• Label: 2003-10-16
• Label: 2015-03-12
• Label: 2017-11-02

Application Sponsors

NDA 021371

EXELTIS USA INC

Marketing Status

• Discontinued: 001

Application Products

001

EMULSION;TOPICAL

0.25%

1

ESTRASORB

ESTRADIOL HEMIHYDRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2003-10-09	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-03-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-11-01	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	8	Null	7

CDER Filings

EXELTIS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21371
            [companyName] => EXELTIS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRASORB","activeIngredients":"ESTRADIOL HEMIHYDRATE","strength":"0.25%","dosageForm":"EMULSION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/01\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021371s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021371s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021371s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/09\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21371_estrasorb_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ESTRASORB","submission":"ESTRADIOL HEMIHYDRATE","actionType":"0.25%","submissionClassification":"EMULSION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-11-01
        )

)