CEROVENE INC FDA Approval ANDA 207849

ANDA 207849

CEROVENE INC

FDA Drug Application

Application #207849

Application Sponsors

ANDA 207849CEROVENE INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG0MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
002TABLET;ORAL5MG0MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE
003TABLET;ORAL10MG0MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-01STANDARD

Submissions Property Types

ORIG1Null29

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

CEROVENE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207849
            [companyName] => CEROVENE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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