ANDA 074026

PLIVA

FDA Drug Application

Application #074026

Application Sponsors

ANDA 074026

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG;37.5MG

0

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; TRIAMTERENE

FDA Submissions

	ORIG	1	AP	1996-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-05-29

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74026
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"25MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","actionType":"25MG;37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)