LANNETT CO INC FDA Approval NDA 201517

NDA 201517

LANNETT CO INC

FDA Drug Application

Application #201517

Documents

Label2011-06-28
Summary Review2012-01-12
Letter2011-06-29
Review2012-01-12
Label2016-12-20
Letter2016-12-21
Label2018-09-24
Label2018-09-24
Letter2018-10-01
Letter2018-10-01
Label2019-10-08
Medication Guide2019-10-08
Letter2019-10-09
Letter2021-03-08
Label2021-03-08
Medication Guide2021-03-08

Application Sponsors

NDA 201517LANNETT CO INC

Marketing Status

Discontinued001

Application Products

001SOLUTION;ORAL100MG/5ML0MORPHINE SULFATEMORPHINE SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2011-06-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2013-07-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2017-01-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2016-02-22STANDARD
LABELING; LabelingSUPPL9AP2016-12-16STANDARD
REMS; REMSSUPPL12AP2018-09-18N/A
LABELING; LabelingSUPPL13AP2018-09-18STANDARD
LABELING; LabelingSUPPL15AP2019-10-07STANDARD
LABELING; LabelingSUPPL17AP2021-03-04STANDARD

Submissions Property Types

ORIG1Null6
SUPPL5Null0
SUPPL8Null0
SUPPL9Null15
SUPPL12Null7
SUPPL13Null7
SUPPL15Null7
SUPPL17Null7

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201517
            [companyName] => LANNETT CO INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/201517s015lbl.pdf#page=28"]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201517s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201517s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201517s012s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-12","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201517s012s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201517s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201517s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201517s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201517s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/23\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201517s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/201517s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/201517_morphine_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/201517Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201517s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/201517Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201517s012s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/201517Orig1s012s013ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-12","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201517s012s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/201517Orig1s012s013ltr.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201517s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201517Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"02\/22\/2016","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2017","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/10\/2013","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-07
        )

)
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