PFIZER INC FDA Approval NDA 207621

NDA 207621

PFIZER INC

FDA Drug Application

Application #207621

Documents

Label2016-08-19
Letter2016-08-19
REMS2016-09-21
FDA Press Release2016-09-21
Letter2016-10-03
Other2016-10-20
REMS2016-11-04
Review2016-12-06
Summary Review2016-12-06
Label2016-12-20
Letter2016-12-21
Medication Guide2016-12-29
Letter2017-05-31

Application Sponsors

NDA 207621PFIZER INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL1.2MG;10MG0TROXYCA ERNALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL2.4MG;20MG0TROXYCA ERNALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL3.6MG;30MG0TROXYCA ERNALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
004CAPSULE, EXTENDED RELEASE;ORAL4.8MG;40MG0TROXYCA ERNALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
005CAPSULE, EXTENDED RELEASE;ORAL7.2MG;60MG0TROXYCA ERNALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
006CAPSULE, EXTENDED RELEASE;ORAL9.6MG;80MG0TROXYCA ERNALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New CombinationORIG1AP2016-08-19STANDARD
LABELING; LabelingSUPPL4AP2016-12-16STANDARD
REMS; REMSSUPPL5AP2017-05-26N/A

Submissions Property Types

ORIG1Null6
SUPPL4Null15
SUPPL5Null15

CDER Filings

PFIZER
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207621
            [companyName] => PFIZER
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/207621s004lbl.pdf#page=32"]
            [products] => [{"drugName":"TROXYCA ER","activeIngredients":"NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"1.2MG;10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TROXYCA ER","activeIngredients":"NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"2.4MG;20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TROXYCA ER","activeIngredients":"NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"3.6MG;30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TROXYCA ER","activeIngredients":"NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"4.8MG;40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TROXYCA ER","activeIngredients":"NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"7.2MG;60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TROXYCA ER","activeIngredients":"NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"9.6MG;80MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"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\\\/207621s004lbl.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\\\/207621s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207621s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207621s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207621Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/207621Orig1toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/207621Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/26\/2017","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207621Orig1s005ltr.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\\\/207621s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207621Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2016","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207621Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-05-26
        )

)
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