RECORDATI RARE FDA Approval NDA 200677

NDA 200677

RECORDATI RARE

FDA Drug Application

Application #200677

Documents

Letter2012-12-21
Letter2013-02-15
Medication Guide2012-12-18
Summary Review2013-01-22
Letter2015-03-18
Label2012-12-17
Label2015-03-19
Review2013-01-22
Label2018-03-13
Letter2018-03-15
Label2019-01-30
Letter2019-02-13
Label2019-04-12
Medication Guide2019-04-12
Letter2019-04-15
Label2020-01-16
Medication Guide2020-01-16
Letter2020-01-16

Application Sponsors

NDA 200677RECORDATI RARE

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SOLUTION;SUBCUTANEOUSEQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)1SIGNIFORPASIREOTIDE DIASPARTATE
002SOLUTION;SUBCUTANEOUSEQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)1SIGNIFORPASIREOTIDE DIASPARTATE
003SOLUTION;SUBCUTANEOUSEQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)1SIGNIFORPASIREOTIDE DIASPARTATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2012-12-14STANDARD
LABELING; LabelingSUPPL2AP2015-03-17STANDARD
LABELING; LabelingSUPPL3AP2018-03-09STANDARD
LABELING; LabelingSUPPL4AP2019-01-29STANDARD
LABELING; LabelingSUPPL5AP2019-04-11STANDARD
EFFICACY; EfficacySUPPL6AP2020-01-15STANDARD

Submissions Property Types

ORIG1Null31
SUPPL2Null15
SUPPL3Null6
SUPPL4Null6
SUPPL5Null7
SUPPL6Null7

CDER Filings

RECORDATI RARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200677
            [companyName] => RECORDATI RARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/200677s006lbl.pdf#page=15"]
            [products] => [{"drugName":"SIGNIFOR","activeIngredients":"PASIREOTIDE DIASPARTATE","strength":"EQ 0.3MG BASE\/ML (EQ 0.3MG BASE\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SIGNIFOR","activeIngredients":"PASIREOTIDE DIASPARTATE","strength":"EQ 0.6MG BASE\/ML (EQ 0.6MG BASE\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SIGNIFOR","activeIngredients":"PASIREOTIDE DIASPARTATE","strength":"EQ 0.9MG BASE\/ML (EQ 0.9MG BASE\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/15\/2020","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/200677s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200677s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200677s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200677s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200677s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/17\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200677s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200677lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/14\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200677lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200677Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/200677Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/200677Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/15\/2020","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/200677s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/200677Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"04\/11\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200677s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/200677Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/29\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200677s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/09\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200677s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/200677Orig1s003,203255Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"03\/17\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200677s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200677Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"02\/13\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200677Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-15
        )

)
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