EISAI INC FDA Approval NDA 020973

NDA 020973

EISAI INC

FDA Drug Application

Application #020973

Documents

Letter2002-05-29
Letter2002-09-30
Letter2003-08-15
Letter2008-07-02
Letter2010-09-08
Letter2012-05-10
Letter2013-04-23
Letter2016-04-06
Letter2014-12-24
Label2003-04-25
Label2002-02-12
Label2008-06-30
Label2010-09-10
Label2011-05-26
Label2013-04-23
Label2014-12-29
Review1999-08-19
Review2012-03-02
Review2003-04-25
Summary Review2008-08-12
Letter1999-08-19
Letter2002-02-12
Letter2002-11-08
Letter2002-09-23
Letter2005-06-07
Letter2011-05-25
Letter2012-10-10
Letter2014-10-21
Label1999-08-19
Label2002-11-08
Label2005-06-07
Label2012-10-09
Label2012-05-10
Label2016-04-05
Label2014-10-16
Review2007-07-06
Other Important Information from FDA2011-12-20
Letter2016-10-26
Label2017-04-06
Label2018-01-10
Letter2018-01-11
Pediatric Statistical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2018-06-11
Medication Guide2018-06-11
Letter2018-06-14
Pediatric Amendment 11900-01-01
Pediatric Amendment 21900-01-01
Pediatric Amendment 31900-01-01
Pediatric Amendment 41900-01-01
Pediatric Amendment 51900-01-01
Pediatric Amendment 61900-01-01
Pediatric Written Request1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Letter2020-11-30
Label2020-11-30
Medication Guide2020-11-30
Letter2022-03-07
Letter2022-03-07
Label2022-03-10
Medication Guide2022-03-10

Application Sponsors

NDA 020973EISAI INC

Marketing Status

Discontinued001
Prescription002

Application Products

001TABLET, DELAYED RELEASE;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ACIPHEXRABEPRAZOLE SODIUM
002TABLET, DELAYED RELEASE;ORAL20MG1ACIPHEXRABEPRAZOLE SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1999-08-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2000-02-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2000-02-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-05-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-02-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-09-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-12-15STANDARD
LABELING; LabelingSUPPL8AP2001-08-15STANDARD
EFFICACY; EfficacySUPPL9AP2002-02-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2001-10-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2001-10-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2002-05-29STANDARD
EFFICACY; EfficacySUPPL13AP2002-11-08STANDARD
LABELING; LabelingSUPPL14AP2002-09-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2002-09-30STANDARD
LABELING; LabelingSUPPL16AP2003-08-01STANDARD
LABELING; LabelingSUPPL20AP2005-06-03STANDARD
EFFICACY; EfficacySUPPL22AP2008-06-30UNKNOWN
LABELING; LabelingSUPPL25AP2010-09-03UNKNOWN
LABELING; LabelingSUPPL28AP2011-05-20901 REQUIRED
LABELING; LabelingSUPPL29AP2012-10-05901 REQUIRED
LABELING; LabelingSUPPL30AP2012-05-08STANDARD
LABELING; LabelingSUPPL32AP2013-04-19STANDARD
LABELING; LabelingSUPPL33AP2016-04-04STANDARD
LABELING; LabelingSUPPL34AP2014-10-15STANDARD
LABELING; LabelingSUPPL35AP2014-12-19901 REQUIRED
LABELING; LabelingSUPPL37AP2016-10-24STANDARD
LABELING; LabelingSUPPL38AP2018-01-09STANDARD
LABELING; LabelingSUPPL39AP2018-06-07STANDARD
LABELING; LabelingSUPPL41AP2020-11-27STANDARD
LABELING; LabelingSUPPL42AP2022-03-04STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL15Null0
SUPPL22Null6
SUPPL25Null7
SUPPL28Null6
SUPPL29Null6
SUPPL30Null6
SUPPL32Null7
SUPPL33Null7
SUPPL34Null7
SUPPL35Null15
SUPPL37Null31
SUPPL38Null15
SUPPL39Null6
SUPPL41Null31
SUPPL42Null6

TE Codes

002PrescriptionAB

CDER Filings

EISAI INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20973
            [companyName] => EISAI INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020973s039lbl.pdf#page=34"]
            [products] => [{"drugName":"ACIPHEX","activeIngredients":"RABEPRAZOLE SODIUM","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ACIPHEX","activeIngredients":"RABEPRAZOLE SODIUM","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/07\/2018","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020973s039lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2018","submission":"SUPPL-38","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020973s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2016","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020973s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2016","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020973s033lbledt.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-35","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020973s035204736s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020973s035204736s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2014","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020973s034,204736s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020973s032lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2012","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020973s029lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2012","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020973s030lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2011","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020973s028lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2010","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020973s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2008","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020973s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2005","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020973s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2002","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20973S013lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2002","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20973s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2001","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20973s8lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20973lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACIPHEX","submission":"RABEPRAZOLE SODIUM","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ACIPHEX","submission":"RABEPRAZOLE SODIUM","actionType":"20MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-06-07
        )

)
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