ANDA 213950

AMNEAL

FDA Drug Application

Application #213950

Application Sponsors

ANDA 213950

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

FILM, EXTENDED RELEASE;TRANSDERMAL

0.035MG/24HR;0.15MG/24HR

0

ETHINYL ESTRADIOL AND NORELGESTROMIN

ETHINYL ESTRADIOL; NORELGESTROMIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-02-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213950
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHINYL ESTRADIOL AND NORELGESTROMIN","activeIngredients":"ETHINYL ESTRADIOL; NORELGESTROMIN","strength":"0.035MG\/24HR;0.15MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-25
        )

)