ANDA 203960

HI TECH

FDA Drug Application

Application #203960

Application Sponsors

ANDA 203960

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

40MG/ML

0

MEGESTROL ACETATE

MEGESTROL ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-09
LABELING; Labeling	SUPPL	2	AP	2020-04-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203960
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEGESTROL ACETATE","activeIngredients":"MEGESTROL ACETATE","strength":"40MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-06
        )

)