ZYDUS FDA Approval ANDA 213055

ANDA 213055

ZYDUS

FDA Drug Application

Application #213055

Application Sponsors

ANDA 213055ZYDUS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-09-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213055
            [companyName] => ZYDUS
            [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":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)

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