TAKEDA PHARMS USA FDA Approval NDA 050757

NDA 050757

TAKEDA PHARMS USA

FDA Drug Application

Application #050757

Documents

Letter1999-01-22
Letter2004-07-30
Letter2006-08-14
Letter2007-06-04
Letter2007-11-08
Letter2009-04-03
Letter2014-12-23
Label1999-10-22
Label2007-11-07
Review1999-01-22
Review1999-08-20
Letter1999-08-20
Letter1999-10-22
Letter2002-11-22
Letter2004-06-14
Letter2004-07-30
Letter2005-04-28
Letter2006-08-14
Letter2013-11-08
Label1999-01-22
Label1999-08-20
Label2002-11-22
Label2004-06-14
Label2005-04-28
Label2013-11-08
Label2014-12-22
Review1997-12-02
Review1999-10-22
Letter2016-10-26
Label2016-10-31
Label2017-03-02
Letter2017-03-03
Label2017-11-30
Letter2017-12-01
Label2018-06-12
Letter2018-06-14

Application Sponsors

NDA 050757TAKEDA PHARMS USA

Marketing Status

Discontinued001

Application Products

001CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG1PREVPACAMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP1997-12-02STANDARD
EFFICACY; EfficacySUPPL2AP1999-01-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-08-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-10-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2001-02-27STANDARD
LABELING; LabelingSUPPL6AP2002-11-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-03-12STANDARD
LABELING; LabelingSUPPL8AP2002-11-22STANDARD
LABELING; LabelingSUPPL9AP2004-07-27STANDARD
LABELING; LabelingSUPPL10AP2004-07-27STANDARD
LABELING; LabelingSUPPL11AP2005-04-20STANDARD
LABELING; LabelingSUPPL12AP2006-08-09STANDARD
LABELING; LabelingSUPPL13AP2006-08-09STANDARD
LABELING; LabelingSUPPL14AP2007-05-31STANDARD
LABELING; LabelingSUPPL15AP2007-10-30STANDARD
LABELING; LabelingSUPPL16AP2009-04-01STANDARD
LABELING; LabelingSUPPL17AP2013-11-06UNKNOWN
LABELING; LabelingSUPPL18AP2017-03-01STANDARD
LABELING; LabelingSUPPL19AP2014-12-19901 REQUIRED
LABELING; LabelingSUPPL20AP2016-10-24901 REQUIRED
LABELING; LabelingSUPPL21AP2017-11-29STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL22AP2018-06-07STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL17Null6
SUPPL18Null6
SUPPL19Null7
SUPPL20Null15
SUPPL21Null6
SUPPL22Null6

CDER Filings

TAKEDA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50757
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREVPAC (COPACKAGED)","activeIngredients":"AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE","strength":"500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/07\/2018","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050757s022lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050757s021lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/01\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050757s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050757s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050757s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050757s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050757s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2007","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050757s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2005","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050757s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2002","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50757slr006,008_prevpac_lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2002","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50757slr006,008_prevpac_lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/1999","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/50-757S004_Prevpac_prntlbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/1999","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/50-757S003_Prevpac_prntlbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/1999","submission":"SUPPL-2","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/50757s2lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PREVPAC (COPACKAGED)","submission":"AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE","actionType":"500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-06-07
        )

)
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