ALLERGAN FDA Approval NDA 022256

NDA 022256

ALLERGAN

FDA Drug Application

Application #022256

Documents

Letter2009-01-14
Letter2009-04-21
Letter2010-02-16
Letter2010-02-16
Letter2011-05-03
Letter2013-10-31
Label2009-01-14
Label2010-02-23
Label2010-02-16
Label2011-11-09
Label2015-01-30
Letter2010-05-21
Letter2011-11-10
Letter2012-11-08
Letter2012-12-11
Letter2013-10-31
Letter2015-02-02
Label2009-04-23
Label2010-05-18
Label2012-12-07
Label2013-10-31
Label2013-10-31
Label2013-06-26
Review2009-03-24
Review2013-08-06
Summary Review2009-01-15
Letter2016-09-06
Label2016-09-06
Label2017-01-03
Letter2017-01-05
Label2017-12-21
Medication Guide2017-12-21
Letter2017-12-27
Label2021-09-21
Medication Guide2021-09-21
Letter2021-09-22

Application Sponsors

NDA 022256ALLERGAN

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL12.5MG1SAVELLAMILNACIPRAN HYDROCHLORIDE
002TABLET;ORAL25MG1SAVELLAMILNACIPRAN HYDROCHLORIDE
003TABLET;ORAL50MG1SAVELLAMILNACIPRAN HYDROCHLORIDE
004TABLET;ORAL100MG1SAVELLAMILNACIPRAN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2009-01-14STANDARD
LABELING; LabelingSUPPL2AP2010-02-01STANDARD
REMS; REMSSUPPL4AP2010-02-02UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2010-06-01N/A
LABELING; LabelingSUPPL6AP2010-05-17UNKNOWN
REMS; REMSSUPPL10AP2011-04-26N/A
LABELING; LabelingSUPPL11AP2011-11-08STANDARD
LABELING; LabelingSUPPL12AP2012-10-30STANDARD
LABELING; LabelingSUPPL13AP2012-12-06STANDARD
LABELING; LabelingSUPPL14AP2013-10-30STANDARD
LABELING; LabelingSUPPL15AP2013-10-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2013-06-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2013-11-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2015-05-21STANDARD
LABELING; LabelingSUPPL19AP2015-01-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2015-06-17STANDARD
LABELING; LabelingSUPPL21AP2016-09-06STANDARD
LABELING; LabelingSUPPL22AP2016-12-30STANDARD
LABELING; LabelingSUPPL23AP2017-12-19STANDARD
LABELING; LabelingSUPPL24AP2022-12-23STANDARD
LABELING; LabelingSUPPL25AP2021-09-20STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL4Null7
SUPPL6Null7
SUPPL10Null6
SUPPL11Null6
SUPPL12Null6
SUPPL13Null7
SUPPL14Null7
SUPPL15Null15
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null15
SUPPL20Null0
SUPPL21Null15
SUPPL22Null6
SUPPL23Null7
SUPPL24Null6
SUPPL25Null7

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22256
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/022256s023lbl.pdf#page=30"]
            [products] => [{"drugName":"SAVELLA","activeIngredients":"MILNACIPRAN HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SAVELLA","activeIngredients":"MILNACIPRAN HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SAVELLA","activeIngredients":"MILNACIPRAN HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SAVELLA","activeIngredients":"MILNACIPRAN HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/19\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022256s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022256s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022256s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022256s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022256s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022256s014s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022256s014s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2013","submission":"SUPPL-16","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022256s016lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/06\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022256s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2011","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022256s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2010","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022256s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2010","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022256s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2010","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022256s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2009","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022256s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2009","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022256s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022256lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SAVELLA","submission":"MILNACIPRAN HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SAVELLA","submission":"MILNACIPRAN HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SAVELLA","submission":"MILNACIPRAN HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SAVELLA","submission":"MILNACIPRAN HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-19
        )

)
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