ALLERGAN FDA Approval NDA 050786

NDA 050786

ALLERGAN

FDA Drug Application

Application #050786

Documents

Letter2011-01-24
Label2007-05-29
Letter2006-10-02
Letter2007-05-29
Letter2013-01-25
Label2013-01-24
Review2006-11-22
Label2017-01-25
Letter2017-01-27
Label2017-06-01
Letter2017-06-02
Letter2018-01-30
Label2018-02-06
Label2018-10-10
Letter2018-10-11
Letter2021-03-09
Label2021-03-09
Label2021-12-17
Letter2021-12-21

Application Sponsors

NDA 050786ALLERGAN

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL140MG;125MG;125MG1PYLERABISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2006-09-28STANDARD
LABELING; LabelingSUPPL3AP2011-01-19STANDARD
LABELING; LabelingSUPPL7AP2013-01-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2013-08-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2013-08-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2014-05-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2014-02-05STANDARD
LABELING; LabelingSUPPL12AP2017-01-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2016-02-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2017-01-19STANDARD
LABELING; LabelingSUPPL16AP2017-05-30STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL17AP2018-01-25STANDARD
LABELING; LabelingSUPPL19AP2018-10-05STANDARD
LABELING; LabelingSUPPL23AP2021-03-05STANDARD
LABELING; LabelingSUPPL25AP2021-12-15STANDARD

Submissions Property Types

ORIG1Null31
SUPPL3Null6
SUPPL7Null6
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null6
SUPPL14Null0
SUPPL16Null6
SUPPL17Null6
SUPPL19Null15
SUPPL23Null6
SUPPL25Null6

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50786
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYLERA","activeIngredients":"BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","strength":"140MG;125MG;125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/05\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050786s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050786s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050786s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050786s016lbl.pdf\"}]","notes":"Please see"},{"actionDate":"01\/25\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050786s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050786s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050786s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2007","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050786s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2007","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050786s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PYLERA","submission":"BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","actionType":"140MG;125MG;125MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-10-05
        )

)

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