ANDA 089097

PLIVA

FDA Drug Application

Application #089097

Application Sponsors

ANDA 089097

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-05-29
LABELING; Labeling	SUPPL	8	AP	2001-10-11
LABELING; Labeling	SUPPL	23	AP	2010-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2014-09-11
LABELING; Labeling	SUPPL	34	AP	2013-01-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	33	Null	15
SUPPL	34	Null	15

TE Codes

001

Prescription

AA

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89097
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)