ANDA 211396

AMNEAL PHARMS

FDA Drug Application

Application #211396

Application Sponsors

ANDA 211396

AMNEAL PHARMS

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	0	ESTRADIOL	ESTRADIOL
002	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	0	ESTRADIOL	ESTRADIOL
003	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	0	ESTRADIOL	ESTRADIOL
004	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	0	ESTRADIOL	ESTRADIOL
005	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	0	ESTRADIOL	ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-02-08

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB3
002	Prescription	AB3
003	Prescription	AB3
004	Prescription	AB3
005	Prescription	AB3

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211396
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.025MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.0375MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.05MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.075MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.1MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-08
        )

)