PLIVA FDA Approval ANDA 089098

ANDA 089098

PLIVA

FDA Drug Application

Application #089098

Application Sponsors

ANDA 089098PLIVA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL100MG0HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1985-12-18
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1994-05-11
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-07-07
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2001-06-15
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2001-05-29
LABELING; LabelingSUPPL8AP2001-10-11
LABELING; LabelingSUPPL23AP2010-11-01
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2014-09-11
LABELING; LabelingSUPPL33AP2013-01-29STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL32Null15
SUPPL33Null15

TE Codes

001PrescriptionAA

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89098
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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