NDA 214383

ONCOPEPTIDES AB

FDA Drug Application

Application #214383

Documents

• Label: 2021-03-01
• Letter: 2021-03-01
• Review: 2021-03-22

Application Sponsors

NDA 214383

ONCOPEPTIDES AB

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG

2

PEPAXTO

MELPHALAN FLUFENAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-02-26

PRIORITY

Submissions Property Types

ORIG

1

Orphan

5

CDER Filings

ONCOPEPTIDES AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214383
            [companyName] => ONCOPEPTIDES AB
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEPAXTO","activeIngredients":"MELPHALAN FLUFENAMIDE","strength":"20MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/26\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214383s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214383s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214383Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-02-26
        )

)