CHIASMA INC FDA Approval NDA 208232

NDA 208232

CHIASMA INC

FDA Drug Application

Application #208232

Documents

Letter2020-06-30
Label2020-07-09

Application Sponsors

NDA 208232CHIASMA INC

Marketing Status

Prescription001

Application Products

001CAPSULE, DELAYED RELEASE; ORAL20MG0MYCAPSSAOCTREOTIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-06-26STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

CHIASMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208232
            [companyName] => CHIASMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCAPSSA","activeIngredients":"OCTREOTIDE ACETATE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208232s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/26\/2020","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\\\/2020\\\/208232s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208232Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-26
        )

)

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