ANDA 203139

TWI PHARMS

FDA Drug Application

Application #203139

Application Sponsors

ANDA 203139

TWI PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

125MG/ML

0

MEGESTROL ACETATE

MEGESTROL ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-08-27
LABELING; Labeling	SUPPL	2	AP	2015-06-08	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-02-21	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	14	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TWI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203139
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEGESTROL ACETATE","activeIngredients":"MEGESTROL ACETATE","strength":"125MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/08\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-21
        )

)