ANDA 081239

ESI

FDA Drug Application

Application #081239

Application Sponsors

ANDA 081239

ESI

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

2.5MG

0

CYCRIN

MEDROXYPROGESTERONE ACETATE

FDA Submissions

	ORIG	1	AP	1992-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-11-28

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

ESI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81239
            [companyName] => ESI
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCRIN","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCRIN","submission":"MEDROXYPROGESTERONE ACETATE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)