ANDA 088907

PAR PHARM

FDA Drug Application

Application #088907

Application Sponsors

ANDA 088907

PAR PHARM

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG;0.125MG

0

RESERPINE AND HYDROFLUMETHIAZIDE

HYDROFLUMETHIAZIDE; RESERPINE

FDA Submissions

	ORIG	1	AP	1985-09-20
LABELING; Labeling	SUPPL	4	AP	1989-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-06-07

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88907
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"RESERPINE AND HYDROFLUMETHIAZIDE","activeIngredients":"HYDROFLUMETHIAZIDE; RESERPINE","strength":"50MG;0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RESERPINE AND HYDROFLUMETHIAZIDE","submission":"HYDROFLUMETHIAZIDE; RESERPINE","actionType":"50MG;0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)