ANDA 204688

BRECKENRIDGE

FDA Drug Application

Application #204688

Application Sponsors

ANDA 204688

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

125MG/ML

0

MEGESTROL ACETATE

MEGESTROL ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-01	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-02-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204688
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEGESTROL ACETATE","activeIngredients":"MEGESTROL ACETATE","strength":"125MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/01\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-24
        )

)