ANDA 088850

PAR PHARM

FDA Drug Application

Application #088850

Application Sponsors

ANDA 088850

PAR PHARM

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDROFLUMETHIAZIDE

HYDROFLUMETHIAZIDE

FDA Submissions

	ORIG	1	AP	1985-05-31
LABELING; Labeling	SUPPL	3	AP	1988-11-14
LABELING; Labeling	SUPPL	4	AP	1991-03-11
LABELING; Labeling	SUPPL	5	AP	1991-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-06-07

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88850
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROFLUMETHIAZIDE","activeIngredients":"HYDROFLUMETHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROFLUMETHIAZIDE","submission":"HYDROFLUMETHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)