PURDUE PHARMA LP FDA Approval NDA 206627

NDA 206627

PURDUE PHARMA LP

FDA Drug Application

Application #206627

Documents

Other2015-11-04
Other2014-12-11
Summary Review2015-04-07
Letter2014-11-20
Letter2015-07-08
Letter2016-04-22
Label2014-11-20
Review2015-04-07
FDA Press Release2014-11-20
Other Important Information from FDA2014-11-20
Letter2016-10-03
Label2016-12-20
Letter2016-12-21
Letter2017-05-31
Label2018-09-21
Label2018-09-21
Letter2018-10-01
Letter2018-10-01
Letter2019-10-08
Label2019-10-09
Medication Guide2019-10-09
Letter2019-11-15
Medication Guide2019-11-15
Letter2021-03-08
Label2021-03-08
Medication Guide2021-03-08

Application Sponsors

NDA 206627PURDUE PHARMA LP

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET, EXTENDED RELEASE;ORAL20MG1HYSINGLA ERHYDROCODONE BITARTRATE
002TABLET, EXTENDED RELEASE;ORAL30MG1HYSINGLA ERHYDROCODONE BITARTRATE
003TABLET, EXTENDED RELEASE;ORAL40MG1HYSINGLA ERHYDROCODONE BITARTRATE
004TABLET, EXTENDED RELEASE;ORAL60MG1HYSINGLA ERHYDROCODONE BITARTRATE
005TABLET, EXTENDED RELEASE;ORAL80MG1HYSINGLA ERHYDROCODONE BITARTRATE
006TABLET, EXTENDED RELEASE;ORAL100MG1HYSINGLA ERHYDROCODONE BITARTRATE
007TABLET, EXTENDED RELEASE;ORAL120MG1HYSINGLA ERHYDROCODONE BITARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2014-11-20PRIORITY
REMS; REMSSUPPL3AP2016-04-20N/A
LABELING; LabelingSUPPL4AP2016-12-16STANDARD
REMS; REMSSUPPL5AP2016-09-30N/A
REMS; REMSSUPPL6AP2017-05-26N/A
REMS; REMSSUPPL7AP2018-09-18N/A
LABELING; LabelingSUPPL8AP2018-09-18STANDARD
REMS; REMSSUPPL9AP2019-11-14N/A
LABELING; LabelingSUPPL10AP2019-10-07STANDARD
LABELING; LabelingSUPPL12AP2021-03-04STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL4Null15
SUPPL5Null6
SUPPL6Null6
SUPPL7Null6
SUPPL8Null7
SUPPL9Null7
SUPPL10Null15
SUPPL12Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB

CDER Filings

PURDUE PHARMA LP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206627
            [companyName] => PURDUE PHARMA LP
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/206627s009MG.pdf"]
            [products] => [{"drugName":"HYSINGLA ER","activeIngredients":"HYDROCODONE BITARTRATE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"HYSINGLA ER","activeIngredients":"HYDROCODONE BITARTRATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYSINGLA ER","activeIngredients":"HYDROCODONE BITARTRATE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYSINGLA ER","activeIngredients":"HYDROCODONE BITARTRATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYSINGLA ER","activeIngredients":"HYDROCODONE BITARTRATE","strength":"80MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYSINGLA ER","activeIngredients":"HYDROCODONE BITARTRATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYSINGLA ER","activeIngredients":"HYDROCODONE BITARTRATE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206627s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206627s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206627s007s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206627s007s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-7","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206627s007s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206627s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206627s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206627s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/20\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206627s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/206627Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206627Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206627Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206627s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206627Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"11\/14\/2019","submission":"SUPPL-9","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206627Orig1s009ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206627s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206627Orig1s007s008ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-7","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206627s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206627Orig1s007s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2017","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206627Orig1s006ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206627Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206627s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206627Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"04\/20\/2016","submission":"SUPPL-3","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206627Orig1s003ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206627Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-14
        )

)
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