PHARMACIA AND UPJOHN FDA Approval NDA 020597

NDA 020597

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020597

Documents

Letter2003-07-28
Letter2003-07-28
Letter2010-09-07
Letter2010-09-07
Letter2014-11-28
Letter2014-11-28
Label2003-04-04
Label2003-04-28
Label2003-04-28
Label2002-08-26
Label2010-09-07
Label2014-12-03
Label2013-03-15
Review2012-01-27
Review2012-01-27
Letter2003-04-04
Letter2002-08-26
Letter2012-03-15
Label2010-09-07
Label2012-03-16
Label2014-12-03
Review2012-01-27
Review2012-01-27
Label2017-04-13
Letter2017-04-14
Review2019-02-15
Letter2020-09-02
Label2020-09-04
Label2022-12-21

Application Sponsors

NDA 020597PHARMACIA AND UPJOHN

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.005%1XALATANLATANOPROST

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1996-06-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-12-09PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-07-31PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-11-01PRIORITY
LABELING; LabelingSUPPL7AP1999-03-22STANDARD
LABELING; LabelingSUPPL8AP1999-07-16STANDARD
EFFICACY; EfficacySUPPL10AP2002-12-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-01-24PRIORITY
LABELING; LabelingSUPPL12AP1999-10-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2000-06-02PRIORITY
LABELING; LabelingSUPPL14AP2000-12-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2000-11-09PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-12-11PRIORITY
LABELING; LabelingSUPPL18AP2000-08-25STANDARD
LABELING; LabelingSUPPL19AP2001-08-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2001-04-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2001-05-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2001-11-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2002-06-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2002-08-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2002-11-15PRIORITY
LABELING; LabelingSUPPL28AP2003-07-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2003-07-14PRIORITY
LABELING; LabelingSUPPL35AP2010-08-31STANDARD
LABELING; LabelingSUPPL36AP2010-08-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2010-07-29N/A
LABELING; LabelingSUPPL44AP2012-03-13STANDARD
LABELING; LabelingSUPPL45AP2014-11-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL46AP2013-03-13PRIORITY
LABELING; LabelingSUPPL48AP2014-11-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL49AP2014-04-03PRIORITY
LABELING; LabelingSUPPL51AP2017-04-10STANDARD
LABELING; LabelingSUPPL52AP2020-09-01STANDARD
LABELING; LabelingSUPPL54AP2022-12-19STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL5Null0
SUPPL6Null0
SUPPL11Null0
SUPPL13Null0
SUPPL16Null0
SUPPL17Null0
SUPPL20Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL26Null0
SUPPL29Null0
SUPPL35Null7
SUPPL36Null6
SUPPL39Null6
SUPPL44Null15
SUPPL45Null6
SUPPL46Null0
SUPPL48Null7
SUPPL49Null0
SUPPL51Null7
SUPPL52Null15
SUPPL54Null6

TE Codes

001PrescriptionAT

CDER Filings

UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20597
            [companyName] => UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"XALATAN","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/01\/2020","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020597s052lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2017","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020597s051lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2014","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020597s045s048lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2014","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020597s045s048lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2013","submission":"SUPPL-46","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020597s046lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/13\/2012","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020597s044lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2010","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020597s035s036lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2010","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020597s035s036lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2002","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20597SE1-010_Xalatan_lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2002","submission":"SUPPL-25","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20597s25lbl.pdf\"}]","notes":""},{"actionDate":"11\/26\/2001","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20597s23lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/08\/2001","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20597s19lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"XALATAN","submission":"LATANOPROST","actionType":"0.005%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)
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