ALKERMES INC FDA Approval NDA 213378

NDA 213378

ALKERMES INC

FDA Drug Application

Application #213378

Documents

Letter2021-06-01
Letter2021-06-01
Label2021-06-01
Label2021-06-01
Medication Guide2021-06-01

Application Sponsors

NDA 213378ALKERMES INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET; ORAL5MG; 10MG2LYBALVIOLANZAPINE; SAMIDORPHAN
002TABLET; ORAL10MG; 10MG2LYBALVIOLANZAPINE; SAMIDORPHAN
003TABLET; ORAL15MG; 20MG2LYBALVIOLANZAPINE; SAMIDORPHAN
004TABLET; ORAL20MG; 10MG2LYBALVIOLANZAPINE; SAMIDORPHAN

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2021-05-28STANDARD
TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG2AP2021-05-28STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null15

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD
004PrescriptionTBD

CDER Filings

Accessdata Error
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    [0] => Array
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            [ApplNo] => 213378
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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