ANDA 085219

AUROLIFE PHARMA LLC

FDA Drug Application

Application #085219

Application Sponsors

ANDA 085219

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1979-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-04-06
LABELING; Labeling	SUPPL	14	AP	1989-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1995-03-28
LABELING; Labeling	SUPPL	17	AP	1992-10-19
LABELING; Labeling	SUPPL	18	AP	1993-03-29
LABELING; Labeling	SUPPL	19	AP	1993-08-17

Submissions Property Types

SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	16	Null	0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85219
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)