PLIVA FDA Approval ANDA 088618

ANDA 088618

PLIVA

FDA Drug Application

Application #088618

Documents

Label2014-04-18
Label2014-06-24
Letter2014-06-11

Application Sponsors

ANDA 088618PLIVA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL25MG0HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1986-01-10
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-02-05
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1986-08-01
LABELING; LabelingSUPPL5AP1991-01-14
LABELING; LabelingSUPPL6AP1994-05-24
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1994-05-11
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-02-06
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-02-06
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-07-07
LABELING; LabelingSUPPL12AP2002-01-30
LABELING; LabelingSUPPL18AP2004-02-04
LABELING; LabelingSUPPL28AP2008-08-05
LABELING; LabelingSUPPL43AP2014-06-05STANDARD
LABELING; LabelingSUPPL44AP2016-03-29STANDARD
LABELING; LabelingSUPPL45AP2016-03-30STANDARD
LABELING; LabelingSUPPL47AP2016-11-08STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL43Null7
SUPPL44Null7
SUPPL45Null15
SUPPL47Null15

TE Codes

001PrescriptionAB

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88618
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/05\/2014","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2008","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/088617s030,088618s028,088619s031lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-06-05
        )

)

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