AM REGENT FDA Approval ANDA 090534

ANDA 090534

AM REGENT

FDA Drug Application

Application #090534

Application Sponsors

ANDA 090534AM REGENT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION25MG/10ML (2.5MG/ML)0NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2009-11-17
LABELING; LabelingSUPPL3AP2015-06-02STANDARD
LABELING; LabelingSUPPL4AP2015-06-02STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15
SUPPL4Null7

TE Codes

001PrescriptionAP

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90534
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"25MG\/10ML (2.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NICARDIPINE HYDROCHLORIDE","submission":"NICARDIPINE HYDROCHLORIDE","actionType":"25MG\/10ML (2.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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