ANDA 088557

HIKMA PHARMS

FDA Drug Application

Application #088557

Application Sponsors

ANDA 088557

HIKMA PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

250MG;0.125MG

0

CHLOROTHIAZIDE AND RESERPINE

CHLOROTHIAZIDE; RESERPINE

FDA Submissions

	ORIG	1	AP	1983-12-22
LABELING; Labeling	SUPPL	7	AP	1989-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-09-20

Submissions Property Types

SUPPL

9

Null

0

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88557
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLOROTHIAZIDE AND RESERPINE","activeIngredients":"CHLOROTHIAZIDE; RESERPINE","strength":"250MG;0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLOROTHIAZIDE AND RESERPINE","submission":"CHLOROTHIAZIDE; RESERPINE","actionType":"250MG;0.125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)