ANDA 206388

TEVA PHARMS USA

FDA Drug Application

Application #206388

Application Sponsors

ANDA 206388

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;VAGINAL

10MCG

0

ESTRADIOL

ESTRADIOL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-07-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-02-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-02-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206388
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"10MCG","dosageForm":"TABLET;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-21
        )

)