ANDA 085098

IMPAX LABS

FDA Drug Application

Application #085098

Application Sponsors

ANDA 085098

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1977-07-15
LABELING; Labeling	SUPPL	16	AP	1991-09-18
LABELING; Labeling	SUPPL	20	AP	1989-11-09
LABELING; Labeling	SUPPL	21	AP	1990-01-23
LABELING; Labeling	SUPPL	22	AP	1990-04-06
LABELING; Labeling	SUPPL	23	AP	1991-01-16
LABELING; Labeling	SUPPL	24	AP	2001-03-16
LABELING; Labeling	SUPPL	25	AP	2001-03-16

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85098
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)