NOVITIUM PHARMA FDA Approval ANDA 213730

ANDA 213730

NOVITIUM PHARMA

FDA Drug Application

Application #213730

Application Sponsors

ANDA 213730NOVITIUM PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL3.75MG0CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM
002TABLET;ORAL7.5MG0CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM
003TABLET;ORAL15MG0CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-06-16STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213730
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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