HIKMA FDA Approval ANDA 212847

ANDA 212847

HIKMA

FDA Drug Application

Application #212847

Application Sponsors

ANDA 212847HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/ML0MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 5MG BASE/ML0MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212847
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-11
        )

)

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