ANDA 089135

PAR PHARM

FDA Drug Application

Application #089135

Application Sponsors

ANDA 089135

PAR PHARM

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

2.5MG

0

METHYCLOTHIAZIDE

METHYCLOTHIAZIDE

FDA Submissions

	ORIG	1	AP	1986-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-06-22
LABELING; Labeling	SUPPL	5	AP	1988-12-14
LABELING; Labeling	SUPPL	6	AP	1992-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-04-01

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89135
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYCLOTHIAZIDE","activeIngredients":"METHYCLOTHIAZIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYCLOTHIAZIDE","submission":"METHYCLOTHIAZIDE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)