ANDA 080209

CONTRACT PHARMACAL

FDA Drug Application

Application #080209

Application Sponsors

ANDA 080209

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

5MG

0

PREDNISONE

PREDNISONE

FDA Submissions

	ORIG	1	AP	1972-07-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1985-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1985-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1985-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1985-09-19

Submissions Property Types

SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80209
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)