RECORDATI RARE FDA Approval NDA 203255

NDA 203255

RECORDATI RARE

FDA Drug Application

Application #203255

Documents

Letter2014-12-16
Review2016-03-02
Summary Review2016-03-02
Label2014-12-16
Label2018-03-13
Letter2018-03-15
Label2018-07-05
Medication Guide2018-07-06
Letter2018-07-06
Label2019-01-30
Letter2019-02-13
Label2019-04-12
Letter2019-04-15
Label2020-07-10
Letter2020-07-10

Application Sponsors

NDA 203255RECORDATI RARE

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001FOR SUSPENSION;INTRAMUSCULAREQ 20MG BASE/VIAL1SIGNIFOR LAR KITPASIREOTIDE PAMOATE
002FOR SUSPENSION;INTRAMUSCULAREQ 40MG BASE/VIAL1SIGNIFOR LAR KITPASIREOTIDE PAMOATE
003FOR SUSPENSION;INTRAMUSCULAREQ 60MG BASE/VIAL1SIGNIFOR LAR KITPASIREOTIDE PAMOATE
004FOR SUSPENSION;INTRAMUSCULAREQ 10MG BASE/VIAL1SIGNIFOR LAR KITPASIREOTIDE PAMOATE
005FOR SUSPENSION;INTRAMUSCULAREQ 30MG BASE/VIAL1SIGNIFOR LAR KITPASIREOTIDE PAMOATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2014-12-15STANDARD
LABELING; LabelingSUPPL2AP2018-03-09STANDARD
EFFICACY; EfficacySUPPL4AP2018-06-29STANDARD
LABELING; LabelingSUPPL5AP2019-01-29STANDARD
LABELING; LabelingSUPPL7AP2019-04-11STANDARD
LABELING; LabelingSUPPL8AP2020-07-09STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL4Null15
SUPPL5Null6
SUPPL7Null15
SUPPL8Null6

CDER Filings

RECORDATI RARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203255
            [companyName] => RECORDATI RARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/203255s004lbl.pdf#page=27"]
            [products] => [{"drugName":"SIGNIFOR LAR KIT","activeIngredients":"PASIREOTIDE PAMOATE","strength":"EQ 20MG BASE\/VIAL","dosageForm":"FOR SUSPENSION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SIGNIFOR LAR KIT","activeIngredients":"PASIREOTIDE PAMOATE","strength":"EQ 40MG BASE\/VIAL","dosageForm":"FOR SUSPENSION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SIGNIFOR LAR KIT","activeIngredients":"PASIREOTIDE PAMOATE","strength":"EQ 60MG BASE\/VIAL","dosageForm":"FOR SUSPENSION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SIGNIFOR LAR KIT","activeIngredients":"PASIREOTIDE PAMOATE","strength":"EQ 10MG BASE\/VIAL","dosageForm":"FOR SUSPENSION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SIGNIFOR LAR KIT","activeIngredients":"PASIREOTIDE PAMOATE","strength":"EQ 30MG BASE\/VIAL","dosageForm":"FOR SUSPENSION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/09\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203255s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203255s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203255s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203255s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203255s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2018","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203255s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203255s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203255s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/15\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203255s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203255Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/203255Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/203255Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/09\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203255s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203255Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203255s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203255Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/29\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203255s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"06\/29\/2018","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203255s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203255Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"03\/09\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203255s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/200677Orig1s003,203255Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/08\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-09
        )

)
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