PAR PHARM INC FDA Approval ANDA 200812

ANDA 200812

PAR PHARM INC

FDA Drug Application

Application #200812

Documents

Review2013-10-24
Other2015-06-30

Application Sponsors

ANDA 200812PAR PHARM INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL20MG0MORPHINE SULFATEMORPHINE SULFATE
002CAPSULE, EXTENDED RELEASE;ORAL30MG0MORPHINE SULFATEMORPHINE SULFATE
003CAPSULE, EXTENDED RELEASE;ORAL50MG0MORPHINE SULFATEMORPHINE SULFATE
004CAPSULE, EXTENDED RELEASE;ORAL60MG0MORPHINE SULFATEMORPHINE SULFATE
005CAPSULE, EXTENDED RELEASE;ORAL80MG0MORPHINE SULFATEMORPHINE SULFATE
006CAPSULE, EXTENDED RELEASE;ORAL100MG0MORPHINE SULFATEMORPHINE SULFATE

FDA Submissions

N/A; Not ApplicableORIG1AP2011-11-10
LABELING; LabelingSUPPL2AP2013-04-24
LABELING; LabelingSUPPL3AP2015-02-06STANDARD
REMS; REMSSUPPL5AP2014-08-19
REMS; REMSSUPPL6AP2015-06-26
REMS; REMSSUPPL8AP2016-04-20
REMS; REMSSUPPL10AP2016-09-30
REMS; REMSSUPPL11AP2017-05-26
REMS; REMSSUPPL13AP2018-09-18

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null15
SUPPL5Null15
SUPPL6Null15
SUPPL8Null15
SUPPL10Null15
SUPPL11Null15
SUPPL13Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

PAR PHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200812
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"80MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/10\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2011\\\/200812Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-13","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2017","submission":"SUPPL-11","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-10","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2016","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2014","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/06\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)

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