ANDA 088946

PAR PHARM

FDA Drug Application

Application #088946

Application Sponsors

ANDA 088946

PAR PHARM

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

50MG;50MG

0

HYDRA-ZIDE

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1985-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-01-10
LABELING; Labeling	SUPPL	10	AP	1988-11-29
LABELING; Labeling	SUPPL	11	AP	1989-01-26
LABELING; Labeling	SUPPL	12	AP	1989-05-08
LABELING; Labeling	SUPPL	14	AP	1991-04-04
LABELING; Labeling	SUPPL	15	AP	1991-06-14
LABELING; Labeling	SUPPL	16	AP	1995-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1997-11-26
LABELING; Labeling	SUPPL	22	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	22	Null	15

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88946
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRA-ZIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","strength":"50MG;50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDRA-ZIDE","submission":"HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE","actionType":"50MG;50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)