ORPHALAN SA FDA Approval NDA 215760

NDA 215760

ORPHALAN SA

FDA Drug Application

Application #215760

Documents

Label2022-04-29
Letter2022-05-02

Application Sponsors

NDA 215760ORPHALAN SA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL300MG0CUVRIORTRIENTINE TETRAHYDROCHLORIDE

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2022-04-28STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

ORPHALAN SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215760
            [companyName] => ORPHALAN SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CUVRIOR","activeIngredients":"TRIENTINE TETRAHYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/28\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215760s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215760s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215760Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-04-28
        )

)

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