ALLERGAN FDA Approval NDA 020616

NDA 020616

ALLERGAN

FDA Drug Application

Application #020616

Documents

Letter2007-03-07
Letter2006-11-06
Letter2013-03-29
Letter2014-04-17
Letter2014-08-20
Letter2015-07-02
Letter2016-04-22
Label2005-09-30
Label2007-03-07
Label2007-04-25
Review2011-02-04
Letter2005-10-20
Letter2007-03-07
Letter2007-05-01
Letter2012-07-11
Letter2013-04-17
Label2007-03-07
Label2006-11-06
Label2012-07-12
Label2012-07-13
Label2014-04-16
Review2007-11-19
Review2007-11-19
Other2012-07-11
Letter2016-10-04
Letter2016-12-20
Label2016-12-21
Letter2017-05-30
Letter2018-09-28
Letter2018-09-28
Label2018-10-12
Label2018-10-12
Label2019-10-08
Medication Guide2019-10-08
Letter2019-10-08
Letter2021-03-05
Label2021-03-08
Medication Guide2021-03-08

Application Sponsors

NDA 020616ALLERGAN

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007
Prescription008
Prescription009
Prescription010
Prescription011
Prescription012

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL20MG1KADIANMORPHINE SULFATE
002CAPSULE, EXTENDED RELEASE;ORAL50MG1KADIANMORPHINE SULFATE
003CAPSULE, EXTENDED RELEASE;ORAL100MG1KADIANMORPHINE SULFATE
004CAPSULE, EXTENDED RELEASE;ORAL30MG1KADIANMORPHINE SULFATE
005CAPSULE, EXTENDED RELEASE;ORAL60MG1KADIANMORPHINE SULFATE
006CAPSULE, EXTENDED RELEASE;ORAL80MG1KADIANMORPHINE SULFATE
007CAPSULE, EXTENDED RELEASE;ORAL200MG1KADIANMORPHINE SULFATE
008CAPSULE, EXTENDED RELEASE;ORAL10MG1KADIANMORPHINE SULFATE
009CAPSULE, EXTENDED RELEASE;ORAL40MG1KADIANMORPHINE SULFATE
010CAPSULE, EXTENDED RELEASE;ORAL70MG1KADIANMORPHINE SULFATE
011CAPSULE, EXTENDED RELEASE;ORAL130MG1KADIANMORPHINE SULFATE
012CAPSULE, EXTENDED RELEASE;ORAL150MG1KADIANMORPHINE SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1996-07-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-04-08STANDARD
LABELING; LabelingSUPPL3AP1999-07-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2001-03-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-02-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2001-02-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2001-12-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2001-12-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2002-03-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2005-09-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2007-02-27STANDARD
LABELING; LabelingSUPPL21AP2007-02-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2006-10-27N/A
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2007-04-20N/A
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2008-01-31N/A
LABELING; LabelingSUPPL36AP2012-07-09STANDARD
REMS; REMSSUPPL41AP2012-07-09N/A
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2012-07-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL46AP2013-01-14STANDARD
REMS; REMSSUPPL47AP2013-04-15N/A
LABELING; LabelingSUPPL48AP2013-03-27STANDARD
LABELING; LabelingSUPPL51AP2014-04-16901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL52AP2014-04-14STANDARD
REMS; REMSSUPPL53AP2014-08-19N/A
REMS; REMSSUPPL54AP2015-06-26N/A
REMS; REMSSUPPL55AP2016-04-20N/A
LABELING; LabelingSUPPL57AP2016-12-16STANDARD
REMS; REMSSUPPL58AP2016-09-30N/A
REMS; REMSSUPPL60AP2017-05-26N/A
REMS; REMSSUPPL61AP2018-09-18N/A
LABELING; LabelingSUPPL62AP2018-09-18STANDARD
LABELING; LabelingSUPPL63AP2019-10-07STANDARD
LABELING; LabelingSUPPL65AP2021-03-04STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL17Null0
SUPPL36Null6
SUPPL41Null15
SUPPL44Null0
SUPPL46Null0
SUPPL47Null6
SUPPL48Null7
SUPPL51Null6
SUPPL52Null0
SUPPL53Null15
SUPPL54Null6
SUPPL55Null6
SUPPL57Null6
SUPPL58Null6
SUPPL60Null6
SUPPL61Null6
SUPPL62Null7
SUPPL63Null15
SUPPL65Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
008PrescriptionAB
009PrescriptionAB
010PrescriptionAB

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20616
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020616s063lbl.pdf#page=34"]
            [products] => [{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"80MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"70MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"130MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KADIAN","activeIngredients":"MORPHINE SULFATE","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020616s063lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-63","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020616s063lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020616s061s062lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-61","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020616s061s062lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020616s057lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020616s057lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-51","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020616s051lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020616s051lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-44","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020616s036s044lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/09\/2012","submission":"SUPPL-41","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020616s041lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2007","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020616s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2007","submission":"SUPPL-25","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020616s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2007","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020616s017s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2007","submission":"SUPPL-17","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020616s017s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2006","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020616s022lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2006","submission":"SUPPL-22","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020616s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2005","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020616s010lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"20MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"50MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"100MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"30MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"60MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"80MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"200MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"10MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"40MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"70MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"130MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"KADIAN","submission":"MORPHINE SULFATE","actionType":"150MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)
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