NDA 214096

EMD SERONO INC

FDA Drug Application

Application #214096

Documents

• Label: 2021-02-03
• Letter: 2021-02-05
• Review: 2021-02-22

Application Sponsors

NDA 214096

EMD SERONO INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

225MG

2

TEPMETKO

TEPOTINIB HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-02-03

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

EMD SERONO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214096
            [companyName] => EMD SERONO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEPMETKO","activeIngredients":"TEPOTINIB HYDROCHLORIDE","strength":"225MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/03\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214096s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/03\/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\\\/214096s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214096Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-02-03
        )

)